Occlusal Morphology Design With Chewing RecordingsNCT07105995
Investigation of Test Foods With Different Hardness and Size on Lower Jaw Movements and Occlusal Morphology Which Designed With Chewing Registrations of Different Test Foods
A study testing Examination and questionnaire, Intraoral scanning and Facebow registrations in people with Occlusal Morphology Design With Chewing Recordings, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
One of the most important goals of prosthetic treatment is to make the occlusal morphology suitable for the patient's original anatomy. Mechanical articulators are metal devices that mimic the temporomandibular joint and lower jaw movements, and attempts have been made to make them patient-specific over the years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occlusal Morphology Design With Chewing Recordings
- What is being tested?
- Examination and questionnaire, Intraoral scanning and Facebow registrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having Angle molar class 1 occlusion
- over 18 years old
- not undergone any orthodontic treatment
- not having any temporomandibular or masticatory disorders
- not having any pain or sensitivity on temporomandibular joint, masticatory muscle
- not having missing teeth or implant-supported restorations
Show all 11Show fewer
- not having fillings or crowns on teeth 4.4 - 4.7
- not having supernumerary teeth
- not allergic to test foods
- volunteering to participate
- being a student at Istanbul University Faculty of Dentistry
Who cannot join
- not having Angle molar class 1 occlusion
- under 18 years old
- undergone any orthodontic treatment
- having any temporomandibular or masticatory disorders
- having any pain or sensitivity on temporomandibular joint, masticatory muscle
- having missing teeth or implant-supported restorations
Show all 11Show fewer
- having fillings or crowns on teeth 4.4 - 4.7
- having supernumerary teeth
- allergic to test foods
- not volunteering to participate
- not being a student at Istanbul University Faculty of Dentistry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Department of Prosthodontics
Istanbul, Süleymaniye Fatih, 34116
Uğur Erdemir, PhD, +902124400000, dishek_dekan@istanbul.edu.tr
aysenurozcan53@gmail.com
About this study
Official title: Effects of Test Foods of Different Hardness and Size on Mandibular Movements and Occlusal Morphology.
One of the most important goals of prosthetic treatment is to make the occlusal morphology suitable for the patient's original anatomy. Mechanical articulators are metal devices that mimic the temporomandibular joint and lower jaw movements, and attempts have been made to make them patient-specific over the years. For this purpose, semi-adjustable articulators were first developed. Later, fully adjustable articulators were introduced to the market. Although these devices have the closest imitation mechanism to the patient's original anatomy, they have various limitations. Adjusting mechanical articulators and recording lower jaw movements have been researched in dentistry clinics and dentistry literature for many years. Due to the limitations of articulators, digital recordings of lower jaw movements have been started since 1989. Later, in 2002, the process of adjusting virtual articulators in a computer environment according to the digital recording data of the mandibular movements was started. In this way, the limitations of mechanical articulators such as metal deformation, difficulties experienced during recording, distortion of plaster and recording material, insufficient stability, adaptation problems of base plates, logistic problems between the laboratory and the physician, and inability to store data have been largely eliminated. In addition, mechanical articulators still cannot fully mimic the anatomy of the temporomandibular joint and related muscles. Digital recording of mandibular movements and transferring them to a virtual environment were first tried with electronic methods, and these systems were developed and ultrasonic and optoelectronic methods were used. Today, tooth movement records can be obtained with 3D video motion analysis methods. By superimposing these data with the data of digital models of the jaws, a mandibular movement recording method has been developed that can now produce restorations without the need for virtual or mechanical articulators. All these developments arise from the desire to record more appropriate and adaptable mandibular movement patterns, overcoming the difficulties in imitating complex patterns of mandibular movements that vary from the size, initial height and consistency of the food to the patient's mental state during the mandibular chewing movement. Thus, we will be able to obtain the most appropriate occlusal morphology for the patient to chew at maximum performance in the prosthetic or restorative procedures we will perform. With the developing technology, mandibular movement recordings can be recorded not only in the border movements as in the past, but also during chewing. In the literature, the majority of studies conducted by having the patient chew a test food are studies measuring the activity of the masticatory muscles, the distance between the incisors, the lateral movement distance or the magnitude of the chewing stroke.
For this reason, in this study, mandibular movements will be recorded with optical motion tracking systems and 4-unit fixed partial dentures(FPDs) for teeth 4.4 - 4.7 will be designed according the recordings.
The study will include individuals who are in the molar class 1 of the Angle classification, who have no temporomandibular joint and masticatory muscle disorders, who have no missing or extra teeth, who have no fillings or crowns on teeth numbered 4.4-4.7, who have not undergone orthodontics, and who are not allergic to the test foods. The subjects will sign a consent form. After the subjects are examined, lower and upper jaw scans and bite scans will be recorded. In the 2nd session, facebow records, border movements and chewing records with 5 different test foods will be recorded from the subjects with an optical lower jaw movement tracker(Zebris JMA Optic). These test foods were selected according to the literature and are cheese, raw carrots, boiled carrots, crispy bread and pre-polymerized silicone impression material. After recordings, fixed partial dentures will be designed via virtual articulator, border movement recordings and for 5 different foods in digital design program. 7 different FDPs designs for each subject will be overlapped with the subject's original anatomy in the Geomagic program.
Read the detailed description
A fundamental objective in prosthodontic rehabilitation is the accurate replication of the patient's native occlusal architecture. Since the early 20th century, dentistry has endeavored to simulate the functional dynamics of the temporomandibular joint (TMJ) and mandibular motion through the use of mechanical articulators-metallic devices engineered to replicate mandibular kinematics. Over time, these articulators have evolved from basic models to more sophisticated, patient-specific systems. Initially, semi-adjustable articulators emerged, followed by the development of fully adjustable variants intended to more closely approximate individual anatomical parameters. Despite their improved accuracy, these devices are not without limitations.
While fully adjustable articulators represent the most anatomically faithful mechanical approximation of mandibular function, they remain inherently limited in precision and adaptability. The calibration of these devices and the accurate documentation of mandibular movements have been subjects of long-standing investigation within both clinical and academic domains of dentistry. In response to the intrinsic shortcomings of mechanical systems-such as susceptibility to material deformation and challenges in capturing dynamic motion-digital motion capture technologies began to emerge in 1989. This transition marked a significant shift toward enhancing the fidelity of mandibular movement analysis.
By 2002, advancements in digital dentistry enabled the integration of virtual articulators within computer-aided design environments, utilizing digitally captured mandibular movement data. This innovation substantially addressed the limitations associated with traditional mechanical articulators, including structural deformation, inaccuracies during physical registration, degradation of plaster or recording media, and logistical inefficiencies in transferring physical components between clinical and laboratory settings. Furthermore, digital systems introduced the critical advantage of data preservation and reproducibility-parameters difficult to achieve with analog models.
Despite ongoing enhancements, mechanical articulators remain incapable of fully replicating the complex anatomical and neuromuscular intricacies of the temporomandibular joint and its associated musculature. Initial efforts to digitally capture mandibular motion involved rudimentary electronic methodologies, which were subsequently refined through the application of ultrasonic and optoelectronic tracking technologies. These innovations significantly improved the spatial resolution and reliability of movement data, enabling more sophisticated integration with virtual modeling systems.
Contemporary techniques now permit the acquisition of mandibular motion data through three-dimensional video-based motion capture systems. When these dynamic recordings are overlaid onto digitized jaw models, a new paradigm in prosthetic design is achieved-allowing for the fabrication of dental restorations without reliance on either virtual or physical articulators. This method not only enhances anatomical precision but also minimizes procedural constraints associated with traditional systems.
These advancements stem from an ongoing pursuit to capture mandibular movements with greater anatomical accuracy and functional adaptability. The inherent complexity of mandibular kinematics-modulated by factors such as food size, texture, and initial occlusal positioning, as well as psychosocial influences during mastication-has historically challenged the capacity of both clinicians and devices to simulate real-world chewing behavior. Digital methodologies offer a more nuanced and individualized representation of these dynamic patterns.
As a result, clinicians are increasingly capable of designing restorations that optimize occlusal morphology, thereby supporting maximal masticatory efficiency in prosthetic and restorative procedures. Technological advancements have expanded the scope of mandibular motion analysis beyond conventional border movements to include real-time recordings captured during functional activities such as chewing. This progression offers a more accurate representation of intraoral dynamics under natural physiological conditions.
The existing body of literature predominantly focuses on the evaluation of masticatory parameters during test food consumption, including electromyographic activity of masticatory muscles, incisal separation distances, lateral excursion amplitudes, and the overall range of chewing cycles. These studies have collectively established that mastication is highly sensitive to the physical properties of food, particularly in relation to its texture, hardness, and size.
It has been well-documented that the nature of food significantly influences mandibular kinematics, with textural variations playing a pivotal role in altering chewing patterns. Numerous studies have investigated how differences in food hardness and dimensional properties affect masticatory behavior, shedding light on the adaptive responses of the jaw during functional loading.
Findings from research examining the influence of food size on mandibular motion generally indicate a positive correlation between food volume and chewing cycle duration. As food size increases, both the intensity of masticatory muscle activation and the amplitude and velocity of mandibular movement tend to rise correspondingly-suggesting a coordinated neuromuscular adaptation to mechanical demands.
With respect to food hardness, there is broad agreement that greater hardness elicits elevated masticatory muscle activity. However, the impact of hardness on other kinematic parameters-such as cycle duration, movement amplitude, and speed-remains inconclusive, reflecting interindividual variability and methodological differences across studies.
Furthermore, the current literature lacks clinical investigations directly comparing the occlusal morphology of prosthetic restorations derived from dynamic chewing records with those fabricated through conventional mechanical or virtual articulator-based methods, including those relying solely on border movement data. This absence underscores a significant knowledge gap regarding the potential functional advantages of mastication-based modeling over traditional techniques.
To address this deficiency, the present study will utilize optoelectronic motion capture systems to record mandibular movements within the Department of Prosthodontics. The study is grounded in the following hypotheses:
Null Hypothesis (H₀):
Variations in the hardness and consistency of test foods do not induce statistically significant angular deviations in mandibular movement patterns.
Alternative Hypotheses:
H₁: Prosthetic restorations designed using functional chewing records do not exhibit differences in occlusal morphology compared to those created via conventional or virtual articulators.
H₂: Patient-specific anatomical parameters-such as condylar path inclination and the Bennett angle-remain consistent across chewing recordings conducted with various test foods.
A statistical power analysis was conducted using G*Power version 3.1.9.7 (Franz Faul, Universität Kiel, Germany), referencing the methodological parameters established in Muric's 2018 study titled "Comparing the Precision of Reproducibility of Computer-Aided Occlusal Design to Conventional Methods." An effect size of 0.25 was applied, with a Type I error rate (α) of 0.20 and a statistical power (1-β) of 80%, resulting in a calculated minimum sample size of 20 participants. To ensure sufficient representation and allow for potential attrition, the final sample size was determined to be 24 individuals. Group comparisons will be analyzed using the Kruskal-Wallis test, while the Mann-Whitney U test will be applied for post hoc pairwise comparisons.
Participants will be recruited from among volunteer students enrolled at the Faculty of Dentistry, Istanbul University. Eligible subjects who meet the inclusion criteria will be identified and registered through the Prosthodontics Clinic. Appointment scheduling will be coordinated jointly with each participant, and subsequent communication will be maintained via telephone. Given the requirement for multiple sessions per participant, ease of accessibility is a key consideration in subject selection.
Since the experimental protocol necessitates the accurate performance of mandibular movements-including laterotrusion, retrusion, and protrusion-participants familiar with these movements are preferred. Accordingly, dental students from Istanbul University, who are both knowledgeable in these functional motions and readily accessible for repeated sessions, have been selected as the study population.
To minimize confounding variables arising from individual anatomical or functional variability, only systemically and dentally healthy individuals will be included. The inclusion criteria are as follows: absence of temporomandibular joint (TMJ) disorders or masticatory muscle dysfunction; no history of orthodontic treatment; intact permanent dentition with Angle Class I molar occlusion (excluding third molars); absence of dental implants, supernumerary teeth, or extensive prosthetic restorations; and no reported orofacial pain or muscle sensitivity. Additionally, participants must not exhibit any allergies or sensitivities to the test foods, and individuals unfamiliar with the selected food items will be excluded to avoid variability due to novelty effects.
The precise execution of mandibular movements during data acquisition is essential, as these recordings directly influence the accuracy and validity of experimental outcomes. In alignment with precedent set by similar research, dental students are often selected as participants due to their familiarity with standard mandibular movement patterns and their ability to follow clinical instructions with consistency. Moreover, their typical age range (18-25 years) aligns well with the study's inclusion criteria, which specify the presence of fully erupted dentition, Angle Class I occlusion, absence of extensive restorations, and no prior prosthetic or orthodontic intervention.
Each participant was assigned a unique identification number ranging from 1 to 24, which was used consistently throughout the study for confidentiality and data tracking purposes. Prior to participation, all subjects were thoroughly informed about the study's objectives, procedures, and potential risks. Informed consent was obtained in writing, confirming their voluntary agreement to participate. Clinical examination of all subjects included the administration of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) developed by Schiffman et al., to ensure the absence of TMJ-related pathology.
Initially, digital impressions of each participant's maxillary and mandibular arches, along with occlusal bite registrations, will be obtained using the Alliedstar intraoral scanner. The acquired datasets will be exported in Standard Tessellation Language (STL) format, enabling the creation of precise digital models for subsequent analysis and design procedures.
Subsequently, mandibular border movements will be documented using the JMA Optic optoelectronic motion capture system (Zebris GmbH, Isny, Germany). The apparatus comprises a head-mounted sensor array and a bite fork affixed to the vestibular surfaces of the mandibular teeth using autopolymerizing acrylic resin (Temdent Temporary Crown and Bridge Acrylic, Schütz Dental GmbH, Rosbach, Germany). This fixation ensures stable signal transmission without impeding mandibular closure. The bite fork is adjusted for proper leveling and retention before being secured in place.
Following acquisition of the facebow registration, the "Border Movement" module within the WinJaw 10.06 software (Zebris GmbH, Isny, Germany) will be activated on a Windows-based workstation. Subject-specific information will be entered into the system, after which the recording of mandibular border movements will commence. Participants will be instructed to perform three repetitions of each predefined mandibular movement-protrusion, retrusion, right laterotrusion, and left laterotrusion-in accordance with the manufacturer's guidelines.
Upon completion of the border movement recordings, participants will be asked to sequentially masticate five standardized test foods exhibiting varying levels of hardness and consistency. Each chewing session will be recorded using the same JMA Optic device under the "Chewing" module of the WinJaw software. These recordings will capture functional mandibular kinematics during real-time mastication for each food item, facilitating a direct comparison of motion dynamics across different material properties.
The test foods selected for this study encompass a spectrum of textural and hardness profiles:
- Soft cheese (Sütaş Dairy Products, Istanbul, Turkey), similar texture to Gouda;
- Raw carrots (hard texture);
- Boiled carrots (20 minutes of boiling in boiling water, moderately soft);
- Crispy bread (UNO Kruton, Istanbul, Turkey);
- Pre-polymerized silicone impression material, used as a substitute for peanuts due to allergy concerns, as approved by the ethics committee. (extremely hard texture, pre-polymerized according to manufacturer's manual)
Each sample will be standardized to dimensions of 10 mm × 10 mm × 10 mm to ensure uniformity in mastication parameters.
Preparation and portioning of all test foods will be conducted under controlled conditions in the Department of Prosthodontics' designated laboratory kitchen. To maintain consistency, stainless steel molds in the form of rectangular prisms (10 × 10 × 10 mm) will be fabricated and used to shape each food sample to identical size specifications. This standardization is critical to eliminating volumetric variability during mastication analysis.
For the chewing motion analysis, the JMA Optic system will be configured via the "Chewing" module in the WinJaw software. As with prior recordings, the sensor fork will be secured to the vestibular surfaces of the mandibular dentition using acrylic resin. Participants will be instructed to chew each food sample for a standardized duration of 20 seconds. The kinematic data from each session will be recorded independently, thereby generating five distinct datasets-corresponding to the five different test foods-that will form Groups 3 through 7 in the final analysis.
Upon completion of all motion and chewing recordings, the digital maxillary and mandibular models of each participant will be imported into the Exocad 3.1 Plovdiv software suite (Exocad GmbH, Darmstadt, Germany). Utilizing the "Wax-up" module, the occlusal and incisal surfaces of the mandibular dentition will be uniformly reduced by approximately 2 millimeters to simulate tooth preparation and establish a baseline for prosthetic occlusal morphology design. This digital modification facilitates the subsequent restorative modeling phase.
Subsequent to model preparation, study cohorts will be established based on the type of mandibular movement data integrated into the design process:
Group 1: Digital models coupled with closure registration data will be mounted on a semi-adjustable virtual articulator (Artex CR, Aman Girrbach, Koblach, Austria) within the design software. Prosthetic restorations will be fabricated using this conventional virtual articulation method.
Group 2: The digital jaw models will be incorporated alongside the optoelectronically recorded border movement trajectories. This dataset will guide the design of prosthetic restorations that account for patient-specific mandibular border kinematics.
Groups 3 to 7: The digital models will be integrated with chewing movement datasets obtained from the five distinct test foods independently. Each chewing dataset will be employed to inform the occlusal morphology design, resulting in five separate restoration designs reflecting functional adaptations to varied masticatory conditions.
The finalized prosthetic occlusal designs will be exported to Geomagic Control X software (3D Systems, Rock Hill, SC, USA) for comprehensive three-dimensional superimposition analysis. This process will quantify linear and angular deviations among the various restoration groups as well as discrepancies relative to the baseline intraoral scans. The software will facilitate precise measurement of spatial differences to assess the fidelity and variability induced by differing mandibular motion inputs.
Furthermore, patient-specific anatomical parameters-such as condylar path inclinations during protrusive movement and Bennett angle metrics-extracted from device-generated reports will be systematically compared across chewing and border movement datasets to evaluate consistency and accuracy.
All statistical analyses will be performed utilizing SPSS version 28.1 (IBM Corp., Armonk, NY, USA). Prior to inferential testing, data distributions will be examined for normality employing the Kolmogorov-Smirnov test. Continuous variables will be summarized as means with standard deviations, whereas categorical variables will be presented as frequencies and percentages.
To assess the agreement between measurement methods, the mean measurement errors for each reference distance will be computed. These will subsequently be evaluated using Bland-Altman plots, appropriate for multiple observations per subject, to visualize and quantify bias and limits of agreement.
For parametric data conforming to normal distribution, group comparisons involving more than two cohorts will be conducted via one-way Analysis of Variance (ANOVA), followed by Tukey's Honestly Significant Difference (HSD) post hoc tests for pairwise group analyses.
Conversely, non-parametric data failing to meet normality assumptions will be compared using the Kruskal-Wallis test for multi-group comparisons. Where significant differences arise, Mann-Whitney U tests will be employed for post hoc pairwise evaluations. To account for multiple testing and control type I error rates, Bonferroni correction will be applied to all post hoc analyses.
A significance threshold will be set at p < 0.05 for all statistical tests.
- Being tested
- Examination and questionnaire, Intraoral scanning, Facebow registrations, Mandibular border movement registrations, Chewing registrations
- Keywords
- occlusal morphology, digital dentistry, jaw motion tracking, virtual articulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination and questionnaireOther
Participants will be enrolled in the study and will complete the Temporomandibular Disorders/Diagnostic Criteria (TMD/DC) questionnaire. Subsequently, the investigator will conduct a clinical examination to assess each participant's eligibility based on the predefined inclusion criteria.
Intraoral scanningOther
The investigator will perform intraoral scanning of the participants' maxillary and mandibular dentitions, as well as record the bite registration.
Facebow registrationsOther
The investigator will perform facebow registrations on the participants utilizing an optoelectronic tracking device.
Mandibular border movement registrationsOther
The investigator will perform mandibular border movement registrations utilizing an optoelectronic mandibular movement tracking device.
Chewing registrationsOther
The investigator will perform 5 chewing registrations with different test foods utilizing an optoelectronic mandibular movement tracking device.
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Experimental | After enrollment of each participants data collection will be started. Data collection is the only arm of the study. This study does not have any control groups of participants. There are 7 different data collection methods. Lower jaw movements and chewing cycles of each participant will be recorded with different methods and occlusal morphologies will be designed with the data collected from each method.
After that, researchers will design occlusal morphologies with collected data and overlap the designs with participants original occlusal anatomy which obtained from intraoral scans. Receives: Other: Examination and questionnaire; Other: Intraoral scanning; Other: Facebow registrations; Other: Mandibular border movement registrations; Other: Chewing registrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear deviation of reference points on occlusal morphology
Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for linear deviations measured in micrometers.
Measured: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Angular deviation of reference points on designed occlusal morphology
Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for angular deviations measured in micrometers."
Measured: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Secondary outcomes (2)
Chewing cycles amplitude
The optical jaw tracking device will record the chewing cycles of each participant. Upon completion of data acquisition, individual chewing cycles associated with each test food will be analyzed. Variations in cycle amplitude will be assessed in relation to the differing hardness and texture of the test foods. All measurements will be expressed in millimeters.
Measured: From enrollment to data collection at 12 weeks. After data collection participants do not take place on designing and analyzing phases.
Chewing cycles width
The optical jaw tracking device will record the chewing cycles of each participant. Upon completion of data acquisition, individual chewing cycles associated with each test food will be analyzed. Variations in cycle width will be assessed in relation to the differing hardness and texture of the test foods. All measurements will be expressed in millimeters.
Measured: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Occlusal Morphology Design With Chewing RecordingsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Özcan-Sezgin, Istanbul University
- Investigators
- Tonguç Sülün, PhD, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105995
- Sponsor's protocol ID
- 2025/102 Rev1
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koch GK, Gallucci GO, Lee SJ. Accuracy in the digital workflow: From data acquisition to the digitally milled cast. J Prosthet Dent. 2016 Jun;115(6):749-54. doi: 10.1016/j.prosdent.2015.12.004. Epub 2016 Jan 21.
PubMed 26803173Kiseri B, Dayan SC, Yildiz M, Sulun T. The correlation between direction and amount of retrusive movement and condyle position and joint space. Cranio. 2018 Jul;36(4):250-256. doi: 10.1080/08869634.2017.1333219. Epub 2017 Jun 3.
PubMed 28578614Kohyama K, Sasaki T, Hayakawa F. Characterization of food physical properties by the mastication parameters measured by electromyography of the jaw-closing muscles and mandibular kinematics in young adults. Biosci Biotechnol Biochem. 2008 Jul;72(7):1690-5. doi: 10.1271/bbb.70769. Epub 2008 Jul 7.
PubMed 18603809Kohyama K, Mioche L, Bourdiol P. Influence of age and dental status on chewing behaviour studied by EMG recordings during consumption of various food samples. Gerodontology. 2003 Jul;20(1):15-23. doi: 10.1111/j.1741-2358.2003.00015.x.
PubMed 12926747Strozyk P, Balchanowski J. Application of numerical simulation studies to determine dynamic loads acting on the human masticatory system during unilateral chewing of selected foods. Front Bioeng Biotechnol. 2023 May 11;11:993274. doi: 10.3389/fbioe.2023.993274. eCollection 2023.
PubMed 37251568Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Bhatka R, Throckmorton GS, Wintergerst AM, Hutchins B, Buschang PH. Bolus size and unilateral chewing cycle kinematics. Arch Oral Biol. 2004 Jul;49(7):559-66. doi: 10.1016/j.archoralbio.2004.01.014.
PubMed 15126137Peyron MA, Lassauzay C, Woda A. Effects of increased hardness on jaw movement and muscle activity during chewing of visco-elastic model foods. Exp Brain Res. 2002 Jan;142(1):41-51. doi: 10.1007/s00221-001-0916-5. Epub 2001 Nov 9.
PubMed 11797083Cheong CW, Radomski K, Otten J, Lee SJ. A clinical comparative analysis using an optical tracking device versus conventional tracking device in the production of occlusal appliances. J Prosthodont. 2025 Apr;34(4):350-356. doi: 10.1111/jopr.13989. Epub 2024 Dec 4.
PubMed 39632348Nigam AA, Lee JD, Lee SJ. A clinical comparison of sagittal condylar inclination and Bennett angle derived from a conventional electronic tracking device and an optical jaw tracking device. J Prosthet Dent. 2025 Aug;134(2):393-398. doi: 10.1016/j.prosdent.2023.10.034. Epub 2023 Nov 28.
PubMed 38030543Muric A, Gokcen Rohlig B, Ongul D, Evlioglu G. Comparing the precision of reproducibility of computer-aided occlusal design to conventional methods. J Prosthodont Res. 2019 Jan;63(1):110-114. doi: 10.1016/j.jpor.2018.10.002. Epub 2018 Nov 13.
PubMed 30446412Lepidi L, Galli M, Mastrangelo F, Venezia P, Joda T, Wang HL, Li J. Virtual Articulators and Virtual Mounting Procedures: Where Do We Stand? J Prosthodont. 2021 Jan;30(1):24-35. doi: 10.1111/jopr.13240. Epub 2020 Sep 2.
PubMed 32827222Anderson K, Throckmorton GS, Buschang PH, Hayasaki H. The effects of bolus hardness on masticatory kinematics. J Oral Rehabil. 2002 Jul;29(7):689-96. doi: 10.1046/j.1365-2842.2002.00862.x.
PubMed 12153460Shiga H, Stohler CS, Kobayashi Y. The effect of bolus size on the chewing cycle in humans. Odontology. 2001 Nov;89(1):49-53. doi: 10.1007/s10266-001-8185-0.
PubMed 14530922Miyawaki S, Ohkochi N, Kawakami T, Sugimura M. Effect of food size on the movement of the mandibular first molars and condyles during deliberate unilateral mastication in humans. J Dent Res. 2000 Jul;79(7):1525-31. doi: 10.1177/00220345000790071601.
PubMed 11005739
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Test Foods of Different Hardness and Size on Mandibular Movements and Occlusal Morphology.
- ClinicalTrials.gov ID
- NCT07105995
- Acronym / sponsor ID
- 2025/102 Rev1
- Keywords
- occlusal morphology, digital dentistry, jaw motion tracking, virtual articulator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most important goals of prosthetic treatment is to make the occlusal morphology suitable for the patient's original anatomy. Mechanical articulators are metal devices that mimic the temporomandibular joint and lower jaw movements, and attempts have been made to make them patient-specific over the years. For this purpose, semi-adjustable articulators were first developed. Later, fully adjustable articulators were introduced to the market. Although these devices have the closest imitation mechanism to the patient's original anatomy, they have various limitations. Adjusting mechanical articulators and recording lower jaw movements have been researched in dentistry clinics and dentistry literature for many years. Due to the limitations of articulators, digital recordings of lower jaw movements have been started since 1989. Later, in 2002, the process of adjusting virtual articulators in a computer environment according to the digital recording data of the mandibular movements was started. In this way, the limitations of mechanical articulators such as metal deformation, difficulties experienced during recording, distortion of plaster and recording material, insufficient stability, adaptation problems of base plates, logistic problems between the laboratory and the physician, and inability to store data have been largely eliminated. In addition, mechanical articulators still cannot fully mimic the anatomy of the temporomandibular joint and related muscles. Digital recording of mandibular movements and transferring them to a virtual environment were first tried with electronic methods, and these systems were developed and ultrasonic and optoelectronic methods were used. Today, tooth movement records can be obtained with 3D video motion analysis methods. By superimposing these data with the data of digital models of the jaws, a mandibular movement recording method has been developed that can now produce restorations without the need for virtual or mechanical articulators. All these developments arise from the desire to record more appropriate and adaptable mandibular movement patterns, overcoming the difficulties in imitating complex patterns of mandibular movements that vary from the size, initial height and consistency of the food to the patient's mental state during the mandibular chewing movement. Thus, we will be able to obtain the most appropriate occlusal morphology for the patient to chew at maximum performance in the prosthetic or restorative procedures we will perform. With the developing technology, mandibular movement recordings can be recorded not only in the border movements as in the past, but also during chewing. In the literature, the majority of studies conducted by having the patient chew a test food are studies measuring the activity of the masticatory muscles, the distance between the incisors, the lateral movement distance or the magnitude of the chewing stroke.
For this reason, in this study, mandibular movements will be recorded with optical motion tracking systems and 4-unit fixed partial dentures(FPDs) for teeth 4.4 - 4.7 will be designed according the recordings.
The study will include individuals who are in the molar class 1 of the Angle classification, who have no temporomandibular joint and masticatory muscle disorders, who have no missing or extra teeth, who have no fillings or crowns on teeth numbered 4.4-4.7, who have not undergone orthodontics, and who are not allergic to the test foods. The subjects will sign a consent form. After the subjects are examined, lower and upper jaw scans and bite scans will be recorded. In the 2nd session, facebow records, border movements and chewing records with 5 different test foods will be recorded from the subjects with an optical lower jaw movement tracker(Zebris JMA Optic). These test foods were selected according to the literature and are cheese, raw carrots, boiled carrots, crispy bread and pre-polymerized silicone impression material. After recordings, fixed partial dentures will be designed via virtual articulator, border movement recordings and for 5 different foods in digital design program. 7 different FDPs designs for each subject will be overlapped with the subject's original anatomy in the Geomagic program.
Detailed description
A fundamental objective in prosthodontic rehabilitation is the accurate replication of the patient's native occlusal architecture. Since the early 20th century, dentistry has endeavored to simulate the functional dynamics of the temporomandibular joint (TMJ) and mandibular motion through the use of mechanical articulators-metallic devices engineered to replicate mandibular kinematics. Over time, these articulators have evolved from basic models to more sophisticated, patient-specific systems. Initially, semi-adjustable articulators emerged, followed by the development of fully adjustable variants intended to more closely approximate individual anatomical parameters. Despite their improved accuracy, these devices are not without limitations.
While fully adjustable articulators represent the most anatomically faithful mechanical approximation of mandibular function, they remain inherently limited in precision and adaptability. The calibration of these devices and the accurate documentation of mandibular movements have been subjects of long-standing investigation within both clinical and academic domains of dentistry. In response to the intrinsic shortcomings of mechanical systems-such as susceptibility to material deformation and challenges in capturing dynamic motion-digital motion capture technologies began to emerge in 1989. This transition marked a significant shift toward enhancing the fidelity of mandibular movement analysis.
By 2002, advancements in digital dentistry enabled the integration of virtual articulators within computer-aided design environments, utilizing digitally captured mandibular movement data. This innovation substantially addressed the limitations associated with traditional mechanical articulators, including structural deformation, inaccuracies during physical registration, degradation of plaster or recording media, and logistical inefficiencies in transferring physical components between clinical and laboratory settings. Furthermore, digital systems introduced the critical advantage of data preservation and reproducibility-parameters difficult to achieve with analog models.
Despite ongoing enhancements, mechanical articulators remain incapable of fully replicating the complex anatomical and neuromuscular intricacies of the temporomandibular joint and its associated musculature. Initial efforts to digitally capture mandibular motion involved rudimentary electronic methodologies, which were subsequently refined through the application of ultrasonic and optoelectronic tracking technologies. These innovations significantly improved the spatial resolution and reliability of movement data, enabling more sophisticated integration with virtual modeling systems.
Contemporary techniques now permit the acquisition of mandibular motion data through three-dimensional video-based motion capture systems. When these dynamic recordings are overlaid onto digitized jaw models, a new paradigm in prosthetic design is achieved-allowing for the fabrication of dental restorations without reliance on either virtual or physical articulators. This method not only enhances anatomical precision but also minimizes procedural constraints associated with traditional systems.
These advancements stem from an ongoing pursuit to capture mandibular movements with greater anatomical accuracy and functional adaptability. The inherent complexity of mandibular kinematics-modulated by factors such as food size, texture, and initial occlusal positioning, as well as psychosocial influences during mastication-has historically challenged the capacity of both clinicians and devices to simulate real-world chewing behavior. Digital methodologies offer a more nuanced and individualized representation of these dynamic patterns.
As a result, clinicians are increasingly capable of designing restorations that optimize occlusal morphology, thereby supporting maximal masticatory efficiency in prosthetic and restorative procedures. Technological advancements have expanded the scope of mandibular motion analysis beyond conventional border movements to include real-time recordings captured during functional activities such as chewing. This progression offers a more accurate representation of intraoral dynamics under natural physiological conditions.
The existing body of literature predominantly focuses on the evaluation of masticatory parameters during test food consumption, including electromyographic activity of masticatory muscles, incisal separation distances, lateral excursion amplitudes, and the overall range of chewing cycles. These studies have collectively established that mastication is highly sensitive to the physical properties of food, particularly in relation to its texture, hardness, and size.
It has been well-documented that the nature of food significantly influences mandibular kinematics, with textural variations playing a pivotal role in altering chewing patterns. Numerous studies have investigated how differences in food hardness and dimensional properties affect masticatory behavior, shedding light on the adaptive responses of the jaw during functional loading.
Findings from research examining the influence of food size on mandibular motion generally indicate a positive correlation between food volume and chewing cycle duration. As food size increases, both the intensity of masticatory muscle activation and the amplitude and velocity of mandibular movement tend to rise correspondingly-suggesting a coordinated neuromuscular adaptation to mechanical demands.
With respect to food hardness, there is broad agreement that greater hardness elicits elevated masticatory muscle activity. However, the impact of hardness on other kinematic parameters-such as cycle duration, movement amplitude, and speed-remains inconclusive, reflecting interindividual variability and methodological differences across studies.
Furthermore, the current literature lacks clinical investigations directly comparing the occlusal morphology of prosthetic restorations derived from dynamic chewing records with those fabricated through conventional mechanical or virtual articulator-based methods, including those relying solely on border movement data. This absence underscores a significant knowledge gap regarding the potential functional advantages of mastication-based modeling over traditional techniques.
To address this deficiency, the present study will utilize optoelectronic motion capture systems to record mandibular movements within the Department of Prosthodontics. The study is grounded in the following hypotheses:
Null Hypothesis (H₀):
Variations in the hardness and consistency of test foods do not induce statistically significant angular deviations in mandibular movement patterns.
Alternative Hypotheses:
H₁: Prosthetic restorations designed using functional chewing records do not exhibit differences in occlusal morphology compared to those created via conventional or virtual articulators.
H₂: Patient-specific anatomical parameters-such as condylar path inclination and the Bennett angle-remain consistent across chewing recordings conducted with various test foods.
A statistical power analysis was conducted using G*Power version 3.1.9.7 (Franz Faul, Universität Kiel, Germany), referencing the methodological parameters established in Muric's 2018 study titled "Comparing the Precision of Reproducibility of Computer-Aided Occlusal Design to Conventional Methods." An effect size of 0.25 was applied, with a Type I error rate (α) of 0.20 and a statistical power (1-β) of 80%, resulting in a calculated minimum sample size of 20 participants. To ensure sufficient representation and allow for potential attrition, the final sample size was determined to be 24 individuals. Group comparisons will be analyzed using the Kruskal-Wallis test, while the Mann-Whitney U test will be applied for post hoc pairwise comparisons.
Participants will be recruited from among volunteer students enrolled at the Faculty of Dentistry, Istanbul University. Eligible subjects who meet the inclusion criteria will be identified and registered through the Prosthodontics Clinic. Appointment scheduling will be coordinated jointly with each participant, and subsequent communication will be maintained via telephone. Given the requirement for multiple sessions per participant, ease of accessibility is a key consideration in subject selection.
Since the experimental protocol necessitates the accurate performance of mandibular movements-including laterotrusion, retrusion, and protrusion-participants familiar with these movements are preferred. Accordingly, dental students from Istanbul University, who are both knowledgeable in these functional motions and readily accessible for repeated sessions, have been selected as the study population.
To minimize confounding variables arising from individual anatomical or functional variability, only systemically and dentally healthy individuals will be included. The inclusion criteria are as follows: absence of temporomandibular joint (TMJ) disorders or masticatory muscle dysfunction; no history of orthodontic treatment; intact permanent dentition with Angle Class I molar occlusion (excluding third molars); absence of dental implants, supernumerary teeth, or extensive prosthetic restorations; and no reported orofacial pain or muscle sensitivity. Additionally, participants must not exhibit any allergies or sensitivities to the test foods, and individuals unfamiliar with the selected food items will be excluded to avoid variability due to novelty effects.
The precise execution of mandibular movements during data acquisition is essential, as these recordings directly influence the accuracy and validity of experimental outcomes. In alignment with precedent set by similar research, dental students are often selected as participants due to their familiarity with standard mandibular movement patterns and their ability to follow clinical instructions with consistency. Moreover, their typical age range (18-25 years) aligns well with the study's inclusion criteria, which specify the presence of fully erupted dentition, Angle Class I occlusion, absence of extensive restorations, and no prior prosthetic or orthodontic intervention.
Each participant was assigned a unique identification number ranging from 1 to 24, which was used consistently throughout the study for confidentiality and data tracking purposes. Prior to participation, all subjects were thoroughly informed about the study's objectives, procedures, and potential risks. Informed consent was obtained in writing, confirming their voluntary agreement to participate. Clinical examination of all subjects included the administration of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) developed by Schiffman et al., to ensure the absence of TMJ-related pathology.
Initially, digital impressions of each participant's maxillary and mandibular arches, along with occlusal bite registrations, will be obtained using the Alliedstar intraoral scanner. The acquired datasets will be exported in Standard Tessellation Language (STL) format, enabling the creation of precise digital models for subsequent analysis and design procedures.
Subsequently, mandibular border movements will be documented using the JMA Optic optoelectronic motion capture system (Zebris GmbH, Isny, Germany). The apparatus comprises a head-mounted sensor array and a bite fork affixed to the vestibular surfaces of the mandibular teeth using autopolymerizing acrylic resin (Temdent Temporary Crown and Bridge Acrylic, Schütz Dental GmbH, Rosbach, Germany). This fixation ensures stable signal transmission without impeding mandibular closure. The bite fork is adjusted for proper leveling and retention before being secured in place.
Following acquisition of the facebow registration, the "Border Movement" module within the WinJaw 10.06 software (Zebris GmbH, Isny, Germany) will be activated on a Windows-based workstation. Subject-specific information will be entered into the system, after which the recording of mandibular border movements will commence. Participants will be instructed to perform three repetitions of each predefined mandibular movement-protrusion, retrusion, right laterotrusion, and left laterotrusion-in accordance with the manufacturer's guidelines.
Upon completion of the border movement recordings, participants will be asked to sequentially masticate five standardized test foods exhibiting varying levels of hardness and consistency. Each chewing session will be recorded using the same JMA Optic device under the "Chewing" module of the WinJaw software. These recordings will capture functional mandibular kinematics during real-time mastication for each food item, facilitating a direct comparison of motion dynamics across different material properties.
The test foods selected for this study encompass a spectrum of textural and hardness profiles:
- Soft cheese (Sütaş Dairy Products, Istanbul, Turkey), similar texture to Gouda;
- Raw carrots (hard texture);
- Boiled carrots (20 minutes of boiling in boiling water, moderately soft);
- Crispy bread (UNO Kruton, Istanbul, Turkey);
- Pre-polymerized silicone impression material, used as a substitute for peanuts due to allergy concerns, as approved by the ethics committee. (extremely hard texture, pre-polymerized according to manufacturer's manual)
Each sample will be standardized to dimensions of 10 mm × 10 mm × 10 mm to ensure uniformity in mastication parameters.
Preparation and portioning of all test foods will be conducted under controlled conditions in the Department of Prosthodontics' designated laboratory kitchen. To maintain consistency, stainless steel molds in the form of rectangular prisms (10 × 10 × 10 mm) will be fabricated and used to shape each food sample to identical size specifications. This standardization is critical to eliminating volumetric variability during mastication analysis.
For the chewing motion analysis, the JMA Optic system will be configured via the "Chewing" module in the WinJaw software. As with prior recordings, the sensor fork will be secured to the vestibular surfaces of the mandibular dentition using acrylic resin. Participants will be instructed to chew each food sample for a standardized duration of 20 seconds. The kinematic data from each session will be recorded independently, thereby generating five distinct datasets-corresponding to the five different test foods-that will form Groups 3 through 7 in the final analysis.
Upon completion of all motion and chewing recordings, the digital maxillary and mandibular models of each participant will be imported into the Exocad 3.1 Plovdiv software suite (Exocad GmbH, Darmstadt, Germany). Utilizing the "Wax-up" module, the occlusal and incisal surfaces of the mandibular dentition will be uniformly reduced by approximately 2 millimeters to simulate tooth preparation and establish a baseline for prosthetic occlusal morphology design. This digital modification facilitates the subsequent restorative modeling phase.
Subsequent to model preparation, study cohorts will be established based on the type of mandibular movement data integrated into the design process:
Group 1: Digital models coupled with closure registration data will be mounted on a semi-adjustable virtual articulator (Artex CR, Aman Girrbach, Koblach, Austria) within the design software. Prosthetic restorations will be fabricated using this conventional virtual articulation method.
Group 2: The digital jaw models will be incorporated alongside the optoelectronically recorded border movement trajectories. This dataset will guide the design of prosthetic restorations that account for patient-specific mandibular border kinematics.
Groups 3 to 7: The digital models will be integrated with chewing movement datasets obtained from the five distinct test foods independently. Each chewing dataset will be employed to inform the occlusal morphology design, resulting in five separate restoration designs reflecting functional adaptations to varied masticatory conditions.
The finalized prosthetic occlusal designs will be exported to Geomagic Control X software (3D Systems, Rock Hill, SC, USA) for comprehensive three-dimensional superimposition analysis. This process will quantify linear and angular deviations among the various restoration groups as well as discrepancies relative to the baseline intraoral scans. The software will facilitate precise measurement of spatial differences to assess the fidelity and variability induced by differing mandibular motion inputs.
Furthermore, patient-specific anatomical parameters-such as condylar path inclinations during protrusive movement and Bennett angle metrics-extracted from device-generated reports will be systematically compared across chewing and border movement datasets to evaluate consistency and accuracy.
All statistical analyses will be performed utilizing SPSS version 28.1 (IBM Corp., Armonk, NY, USA). Prior to inferential testing, data distributions will be examined for normality employing the Kolmogorov-Smirnov test. Continuous variables will be summarized as means with standard deviations, whereas categorical variables will be presented as frequencies and percentages.
To assess the agreement between measurement methods, the mean measurement errors for each reference distance will be computed. These will subsequently be evaluated using Bland-Altman plots, appropriate for multiple observations per subject, to visualize and quantify bias and limits of agreement.
For parametric data conforming to normal distribution, group comparisons involving more than two cohorts will be conducted via one-way Analysis of Variance (ANOVA), followed by Tukey's Honestly Significant Difference (HSD) post hoc tests for pairwise group analyses.
Conversely, non-parametric data failing to meet normality assumptions will be compared using the Kruskal-Wallis test for multi-group comparisons. Where significant differences arise, Mann-Whitney U tests will be employed for post hoc pairwise evaluations. To account for multiple testing and control type I error rates, Bonferroni correction will be applied to all post hoc analyses.
A significance threshold will be set at p < 0.05 for all statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | Experimental | Other: Examination and questionnaire, Other: Intraoral scanning, Other: Facebow registrations, Other: Mandibular border movement registrations, Other: Chewing registrationsAfter enrollment of each participants data collection will be started. Data collection is the only arm of the study. This study does not have any control groups of participants. There are 7 different data collection methods. Lower jaw movements and chewing cycles of each participant will be recorded with different methods and occlusal morphologies will be designed with the data collected from each method. After that, researchers will design occlusal morphologies with collected data and overlap the designs with participants original occlusal anatomy which obtained from intraoral scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- having Angle molar class 1 occlusion
- over 18 years old
- not undergone any orthodontic treatment
- not having any temporomandibular or masticatory disorders
- not having any pain or sensitivity on temporomandibular joint, masticatory muscle
Key exclusion criteria (11 listed)
- not having Angle molar class 1 occlusion
- under 18 years old
- undergone any orthodontic treatment
- having any temporomandibular or masticatory disorders
- having any pain or sensitivity on temporomandibular joint, masticatory muscle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination and questionnaireParticipants will be enrolled in the study and will complete the Temporomandibular Disorders/Diagnostic Criteria (TMD/DC) questionnaire. Subsequently, the investigator will conduct a clinical examination to assess each participant's eligibility based on the predefined inclusion criteria. | Other | Data collection |
| Intraoral scanningThe investigator will perform intraoral scanning of the participants' maxillary and mandibular dentitions, as well as record the bite registration. | Other | Data collection |
| Facebow registrationsThe investigator will perform facebow registrations on the participants utilizing an optoelectronic tracking device. | Other | Data collection |
| Mandibular border movement registrationsThe investigator will perform mandibular border movement registrations utilizing an optoelectronic mandibular movement tracking device. | Other | Data collection |
| Chewing registrationsThe investigator will perform 5 chewing registrations with different test foods utilizing an optoelectronic mandibular movement tracking device. | Other | Data collection |
Primary outcome
Linear deviation of reference points on occlusal morphology
Time frame: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for linear deviations measured in micrometers.
Angular deviation of reference points on designed occlusal morphology
Time frame: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for angular deviations measured in micrometers."
2 secondary outcomes
Chewing cycles amplitude
Time frame: From enrollment to data collection at 12 weeks. After data collection participants do not take place on designing and analyzing phases.
Chewing cycles width
Time frame: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 26803173Koch GK, Gallucci GO, Lee SJ. Accuracy in the digital workflow: From data acquisition to the digitally milled cast. J Prosthet Dent. 2016 Jun;115(6):749-54. doi: 10.1016/j.prosdent.2015.12.004. Epub 2016 Jan 21.
- Background: PubMed 28578614Kiseri B, Dayan SC, Yildiz M, Sulun T. The correlation between direction and amount of retrusive movement and condyle position and joint space. Cranio. 2018 Jul;36(4):250-256. doi: 10.1080/08869634.2017.1333219. Epub 2017 Jun 3.
- Background: PubMed 18603809Kohyama K, Sasaki T, Hayakawa F. Characterization of food physical properties by the mastication parameters measured by electromyography of the jaw-closing muscles and mandibular kinematics in young adults. Biosci Biotechnol Biochem. 2008 Jul;72(7):1690-5. doi: 10.1271/bbb.70769. Epub 2008 Jul 7.
- Background: PubMed 12926747Kohyama K, Mioche L, Bourdiol P. Influence of age and dental status on chewing behaviour studied by EMG recordings during consumption of various food samples. Gerodontology. 2003 Jul;20(1):15-23. doi: 10.1111/j.1741-2358.2003.00015.x.
- Background: PubMed 37251568Strozyk P, Balchanowski J. Application of numerical simulation studies to determine dynamic loads acting on the human masticatory system during unilateral chewing of selected foods. Front Bioeng Biotechnol. 2023 May 11;11:993274. doi: 10.3389/fbioe.2023.993274. eCollection 2023.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 15126137Bhatka R, Throckmorton GS, Wintergerst AM, Hutchins B, Buschang PH. Bolus size and unilateral chewing cycle kinematics. Arch Oral Biol. 2004 Jul;49(7):559-66. doi: 10.1016/j.archoralbio.2004.01.014.
- Background: PubMed 11797083Peyron MA, Lassauzay C, Woda A. Effects of increased hardness on jaw movement and muscle activity during chewing of visco-elastic model foods. Exp Brain Res. 2002 Jan;142(1):41-51. doi: 10.1007/s00221-001-0916-5. Epub 2001 Nov 9.
- Background: PubMed 39632348Cheong CW, Radomski K, Otten J, Lee SJ. A clinical comparative analysis using an optical tracking device versus conventional tracking device in the production of occlusal appliances. J Prosthodont. 2025 Apr;34(4):350-356. doi: 10.1111/jopr.13989. Epub 2024 Dec 4.
- Background: PubMed 38030543Nigam AA, Lee JD, Lee SJ. A clinical comparison of sagittal condylar inclination and Bennett angle derived from a conventional electronic tracking device and an optical jaw tracking device. J Prosthet Dent. 2025 Aug;134(2):393-398. doi: 10.1016/j.prosdent.2023.10.034. Epub 2023 Nov 28.
- Background: PubMed 30446412Muric A, Gokcen Rohlig B, Ongul D, Evlioglu G. Comparing the precision of reproducibility of computer-aided occlusal design to conventional methods. J Prosthodont Res. 2019 Jan;63(1):110-114. doi: 10.1016/j.jpor.2018.10.002. Epub 2018 Nov 13.
- Background: PubMed 32827222Lepidi L, Galli M, Mastrangelo F, Venezia P, Joda T, Wang HL, Li J. Virtual Articulators and Virtual Mounting Procedures: Where Do We Stand? J Prosthodont. 2021 Jan;30(1):24-35. doi: 10.1111/jopr.13240. Epub 2020 Sep 2.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tonguç Sülün, PhD study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examination and questionnaire, Intraoral scanning and Facebow registrations in people with Occlusal Morphology Design With Chewing Recordings, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYŞENUR ÖZCAN-SEZGİN, DDS (+905057667873, aysenurozcan53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear deviation of reference points on occlusal morphology (time frame: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07105995, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.