Jaw TrackingNCT06773728
Evaluation of the Impact of Integrating Dynamic Patient-Specific Motion and Implementing a Jaw Tracking System in the Attribution of the Occlusion in Full-Arch Restorations Through a Digital Workflow: A Clinical Study
An observational study of Jaw Tracking and Occlusion, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The maxillomandibular relationship of diagnostic and definitive casts is a fundamental procedure in prosthodontics. Depending on the prosthodontic treatment involvement, different maxillomandibular relationship records can be selected, including maximal intercuspal position (MIP), centric relation (CR) or most… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Jaw Tracking, Occlusion
- What is being tested?
- Record occlusal contacts and Tracking of jaw movement
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2025to 25 Mar 2025
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the university's clinic
Who may be able to join
- Patient age ≥ 18 years Patients with ≥ 10 teeth in each dental arch
Who cannot join
- Patients with a local or systemic conditions contra-indicating dental treatment (hypertension, a heart attack < 1 year, a stroke < 1 year, uncontrolled cardiovascular diseases, uncontrolled diabetes , immunodeficiency, active oral infection as active herpetic lesions etc.) Pregnancy Fully edentulous patients Presence of craniofacial syndromes Patients age <18 Association with an active orofacial trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
Clinic
Athens, Attica, 11527
Papazoglou Efstratios, DDS, MSc,PhD, 698-512-2220 ext. 30, spapazog@otenet.gr
About this study
Official title: Evaluation of the Impact of Integrating Dynamic Patient-Specific Motion by Implementing Jaw Tracking Systems and Artificial-intelligence Tools in the Attribution of the Occlusion in Full Arch Restorations Through a Digital Workflow: A Clinical Study
The maxillomandibular relationship of diagnostic and definitive casts is a fundamental procedure in prosthodontics. Depending on the prosthodontic treatment involvement, different maxillomandibular relationship records can be selected, including maximal intercuspal position (MIP), centric relation (CR) or most comfortable position. Intraoral scanners (IOSs) provide a digital alternative to obtain diagnostic and definitive casts, as well as the maxillomandibular relationship, by acquiring virtual occlusal records.4 Various techniques are available for tracking and recording the mandibular motion of the patient, including mechanical, photographic, radiographic, electromagnetic, ultrasonic-based devices, and optical motion capturing systems. By implementing a digital jaw tracker, patient's individualized mandibular movement can be recorded and combined with intraoral patient's scan, in order to be simulated through the cad software. However, the accuracy of the maxillomandibular relationship has been evaluated only by one study and for one patient. Also, the accuracy to record and replicate of occlusal contacts, acquired by using optical jaw tracking systems has not been evaluated clinically yet. The purpose of the present study was to clinically evaluate the impact of integrating dynamic patient specific-motion and registration, utilizing a digital jaw analyzer (ModJaw), in the attribution of the occlusion.
Read the detailed description
Patients that are already have been planned for a prosthetic treatment are going to be included in the present research. The records that are used in order to perform an static and a dynamic registration of the occlusion and are standard of care in prosthodontic clinic, will be performed and be obtained by the PI.
In the 1st appointment for each participant a digital impression, as well as a bite registration of the patient will take place in maximal intercuspation(MI) and in the centric relation(CR) implementing am intraoral scanner.(Trios 4, 3Shape).
Patient's individualized dynamic jaw motion will be also recorded by a digital jaw tracking device (ModJaw). In the same appointment patient's contact points will be digitally captured by the scan of the existing teeth or restorations, after the use of an articulating film (8μ , TrollFoil).
Two prototypes utilizing the registration of the jaw tracker in CR and in MCP and two prototypes utilizing the registration that was obtained by the intraoral scanner will be designed. Prototypes will be designed in order to be able to fit over the patient's existing denture.
In the 2nd appointment prototypes will be checked intraorally by implementing an articulating film. An intraoral scan will be performed in order to digitally capture the intraoral markings. Finally patients will be asked to fill out a Visual Analog Scale from 0-100, in order to express "How comfortable they fill their bite, for each one of the prototypes". The questionnaire will be anonymized.
- Conditions
- Jaw Tracking, Occlusion
- Being tested
- Record occlusal contacts, Tracking of jaw movement
- Keywords
- jaw tracking, dental occlusion, artificial intelligence, maxillomandibular position
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Record occlusal contactsDevice
Register using a digital device (t-scan) the occlusal contacts
Tracking of jaw movementDevice
An optical jaw tracking system (Modjaw, Modjaw) is going to be implemented
Tracking of jaw movementDevice
Jaw tracking will be performed using an optical jaw tracking system (Zebris, Zebris medical)
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Device: Record occlusal contacts; Device: Tracking of jaw movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal contacts
The total number of the true positive and the false positive occlusal contacts between the maxillomandibular relationship obtained from each investigated method is going to be assessed
Measured: From the same appointment
Secondary outcomes (1)
Patient's acceptance
The mean score for each investigated method, as it will be obtained from the visual analog scale, will be assessed.
Measured: The visual analog scale records are going to be obtained in the same appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw TrackingStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Ntovas, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773728
- Sponsor's protocol ID
- STUDY0234:
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To further protect patient's data and increase blindness during data analyses
Publications
Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6.
PubMed 36889536Revilla-Leon M, Zeitler JM, Fry E, Kois JC. Digital workflow to measure the mandibular range of motion using different jaw tracking technologies. J Prosthet Dent. 2025 Oct;134(4):1208-1215. doi: 10.1016/j.prosdent.2023.12.018. Epub 2024 Jan 18.
PubMed 38242763Kois JC, Zeitler JM, Revilla-Leon M. Use of an optical jaw tracking system to capture the envelope of function when designing interim and definitive prostheses: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1472-1479. doi: 10.1016/j.prosdent.2024.03.048. Epub 2024 May 18.
PubMed 38762385Taut M, Chanteux S, Kui A, Buduru R, Negucioiu M, Manziuc M, Gheorghiu I, Hedesiu M, Buduru S, Ilea A. Condylar Parameters and Mandibular Movement Patterns in Bruxers Using an Optical Jaw Tracking System. J Clin Med. 2024 Dec 19;13(24):7761. doi: 10.3390/jcm13247761.
PubMed 39768684
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Integrating Dynamic Patient-Specific Motion by Implementing Jaw Tracking Systems and Artificial-intelligence Tools in the Attribution of the Occlusion in Full Arch Restorations Through a Digital Workflow: A Clinical Study
- ClinicalTrials.gov ID
- NCT06773728
- Acronym / sponsor ID
- STUDY0234:
- Conditions
- Jaw Tracking, Occlusion
- Keywords
- jaw tracking, dental occlusion, artificial intelligence, maxillomandibular position
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 14 Jan 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.
The maxillomandibular relationship of diagnostic and definitive casts is a fundamental procedure in prosthodontics. Depending on the prosthodontic treatment involvement, different maxillomandibular relationship records can be selected, including maximal intercuspal position (MIP), centric relation (CR) or most comfortable position. Intraoral scanners (IOSs) provide a digital alternative to obtain diagnostic and definitive casts, as well as the maxillomandibular relationship, by acquiring virtual occlusal records.4 Various techniques are available for tracking and recording the mandibular motion of the patient, including mechanical, photographic, radiographic, electromagnetic, ultrasonic-based devices, and optical motion capturing systems. By implementing a digital jaw tracker, patient's individualized mandibular movement can be recorded and combined with intraoral patient's scan, in order to be simulated through the cad software. However, the accuracy of the maxillomandibular relationship has been evaluated only by one study and for one patient. Also, the accuracy to record and replicate of occlusal contacts, acquired by using optical jaw tracking systems has not been evaluated clinically yet. The purpose of the present study was to clinically evaluate the impact of integrating dynamic patient specific-motion and registration, utilizing a digital jaw analyzer (ModJaw), in the attribution of the occlusion.
Detailed description
Patients that are already have been planned for a prosthetic treatment are going to be included in the present research. The records that are used in order to perform an static and a dynamic registration of the occlusion and are standard of care in prosthodontic clinic, will be performed and be obtained by the PI.
In the 1st appointment for each participant a digital impression, as well as a bite registration of the patient will take place in maximal intercuspation(MI) and in the centric relation(CR) implementing am intraoral scanner.(Trios 4, 3Shape).
Patient's individualized dynamic jaw motion will be also recorded by a digital jaw tracking device (ModJaw). In the same appointment patient's contact points will be digitally captured by the scan of the existing teeth or restorations, after the use of an articulating film (8μ , TrollFoil).
Two prototypes utilizing the registration of the jaw tracker in CR and in MCP and two prototypes utilizing the registration that was obtained by the intraoral scanner will be designed. Prototypes will be designed in order to be able to fit over the patient's existing denture.
In the 2nd appointment prototypes will be checked intraorally by implementing an articulating film. An intraoral scan will be performed in order to digitally capture the intraoral markings. Finally patients will be asked to fill out a Visual Analog Scale from 0-100, in order to express "How comfortable they fill their bite, for each one of the prototypes". The questionnaire will be anonymized.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Record occlusal contacts, Device: Tracking of jaw movement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the university's clinic
Key inclusion criteria (1 listed)
- Patient age ≥ 18 years Patients with ≥ 10 teeth in each dental arch
Key exclusion criteria (1 listed)
- Patients with a local or systemic conditions contra-indicating dental treatment (hypertension, a heart attack < 1 year, a stroke < 1 year, uncontrolled cardiovascular diseases, uncontrolled diabetes , immunodeficiency, active oral infection as active herpetic lesions etc.) Pregnancy Fully edentulous patients Presence of craniofacial syndromes Patients age <18 Association with an active orofacial trauma
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 |
|---|---|---|
| Record occlusal contactsRegister using a digital device (t-scan) the occlusal contacts | Device | Control |
| Tracking of jaw movementAn optical jaw tracking system (Modjaw, Modjaw) is going to be implemented | Device | Control |
| Tracking of jaw movementJaw tracking will be performed using an optical jaw tracking system (Zebris, Zebris medical) | Device | Control |
Primary outcome
Occlusal contacts
Time frame: From the same appointment
The total number of the true positive and the false positive occlusal contacts between the maxillomandibular relationship obtained from each investigated method is going to be assessed
1 secondary outcome
Patient's acceptance
Time frame: The visual analog scale records are going to be obtained in the same appointment.
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 14 Jan 2025.
- Results publication: PubMed 36889536Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6.
- Results publication: PubMed 38242763Revilla-Leon M, Zeitler JM, Fry E, Kois JC. Digital workflow to measure the mandibular range of motion using different jaw tracking technologies. J Prosthet Dent. 2025 Oct;134(4):1208-1215. doi: 10.1016/j.prosdent.2023.12.018. Epub 2024 Jan 18.
- Results publication: PubMed 38762385Kois JC, Zeitler JM, Revilla-Leon M. Use of an optical jaw tracking system to capture the envelope of function when designing interim and definitive prostheses: A dental technique. J Prosthet Dent. 2025 Nov;134(5):1472-1479. doi: 10.1016/j.prosdent.2024.03.048. Epub 2024 May 18.
- Results publication: PubMed 39768684Taut M, Chanteux S, Kui A, Buduru R, Negucioiu M, Manziuc M, Gheorghiu I, Hedesiu M, Buduru S, Ilea A. Condylar Parameters and Mandibular Movement Patterns in Bruxers Using an Optical Jaw Tracking System. J Clin Med. 2024 Dec 19;13(24):7761. doi: 10.3390/jcm13247761.
- Individual participant dataSharing planned: No. To further protect patient's data and increase blindness during data analyses
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw Tracking and Occlusion, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Jan 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 Greece. 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 Panagiotis C Ntovas, DDS, MSc (698-512-2220 ext. 30, pan.ntovas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal contacts (time frame: From the same appointment). 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 NCT06773728, which also lists 4 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 14 Jan 2025.