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Restoration DesignNCT07295964

Accuracy of Intraoral Scan Post-processing Methods: A Clinical Trial

A study testing Artificial intelligence driven registration and Software based registration in people with Restoration Design and Digital Occlusal Collision, run by National and Kapodistrian University of Athens at 1 site in Greece.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In the last decade, progressive developments in computer hardware, software, manufacturing technologies, and dental materials consistently enhanced the use of digital technologies in dentistry. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Artificial intelligence driven registration and Software based registration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGreece
Study dates
25 Jan 2026to 25 Jun 2027
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

  • Age > 18 years old Absence of painful temporomandibular disorder Presence of opposing teeth Presence of a stable maximum intercuspation relationship

Who cannot join

  • Pain in orofacial region Visible periapical lesion < Class II mobility

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Panagiotis Ntovas, DDS, MSc contact

6985122220 ext. 30

pan.ntovas@gmail.com

Greece1 site
  • Clinic

    Athens, Attica, 11527

    Aspasia Sarafianou, DDS, MSc,PhD, 6985122220 ext. 30, ASPASAR@DENT.UOA.GR

Other trials in Greece

About this study

Official title: Influence of AI Driven Software Programs and Digital Occlusal Collision Corrections on the Occlusal Adjustment of 3D-Printed Restorations: A Clinical Trial

In the last decade, progressive developments in computer hardware, software, manufacturing technologies, and dental materials consistently enhanced the use of digital technologies in dentistry. Traditional prosthodontic techniques have relied on manual fabrication processes, which often resulted in challenges such as suboptimal prosthesis fit, compromised occlusal stability, and limited customization options. However, the advent of 3D printing technology has revolutionized the field, offering new possibilities for patient-specific prosthodontic rehabilitation.

An accurate maxillomandibular relationship between the maxillary and mandibular casts is fundamental to prosthodontic practice. In the integration of intraoral scanners (IOSs) for different dental interventions, the accuracy of the digitizing methods recording the maxillomandibular relationship is similarly essential. The maxillomandibular relationship accuracy recorded by using IOSs has been analyzed in various in vitro and clinical studies.

Read more

Intraoral digital scans are recorded in an unload condition, with the mouth open, while acquiring the maxillary and the mandibular intraoral scans. This condition changes when capturing the virtual occlusal records at maximum intercuspation position (MIP). Occlusal collisions are caused by the tooth location discrepancy resulting from the periodontal ligament plasticity between the recording of the intraoral digital scans and the virtual occlusal records, as well as from the intraoral scanning distortion and alignment procedures.

Artificial intelligence driven program software and occlusal collisions or mesh interpenetrations tools have been proposed to improve the maxillomandibular relationship of the scanned models. The software programs of the IOSs can automatically eliminate the occlusal collisions present in virtual articulated casts. Similarly, dental computer-aided design (CAD) programs can automatically detect and eliminate occlusal collisions among the articulated intraoral digital scans imported. However, the effect of the occlusal collision corrections performed by using IOSs or CAD programs on the occlusal adjustment of the restorations is unknown.

Read the detailed description

Objectives The goal of this clinical investigation is to assess the impact of occlusal collision corrections performed by the software program of 2 intraoral scanners (TRIOS 4; 3Shape A/S, i700; Medit) and two dental CAD programs (DentalCAD, Rijeka; exocad \& Dental System ;3Shape), for maxillomandibular relationship acquired at maximum intercuspation position, on the intraoral occlusal adjustment of 3D-printed restorations. The null hypothesis was that no difference would be found for the intraoral occlusal adjustment of the assessed 3D-printed restorations, designed by the different collision correction methods, independently of the IOS and the dental CAD software.

Materials and methods In total 30 patients are going to be enrolled in the present study. Initially, two intraoral scanners will be used to record the experimental digital scans: TRIOS 4 (TRIOS 4, wireless, v. 22.2.3; 3Shape A/S) and i700 (i700, Medit). Two groups will be established depending on the correction of the occlusal collisions performed by using the IOS software program: not corrected and corrected group. Moreover, 3 subgroups will be established based on the following correction procedures performed in a dental CAD program (DentalCAD, Rijeka; exocad GmbH): no changes, cast trimming (trimming subgroup), opening of the vertical dimension (opening subgroup).

For each record a model-free complete digital workflow will be employed to print a crown using a 3D printer (Pro 2, Sprintray) with a compatible resin (KeyDenture Try-in, KeystoneIndustries). Each restoration is going to be tried and fit intraorally. The sequence of try-in will be randomized. Initially, after adjusting for distal and mesial approximal contact areas, the internal fit will be checked and adjusted to eliminate any interferences in order to ensure the optimal fitting of the restorations. After ensuring optimal fitting, the investigator will take an intraoral quadrant scan including the crown.

The occlusal adjustment strategy will be as follows: Under normal occlusal forces, 8 μm articulating film (AccuFilm, FastCheck, Parkell) will be used consecutively, followed by occlusal contact check using 8 μm articulation foil (Shimstock-foil, Bausch, Cologne, Germany) under strong occlusal forces. Then the occlusal adjustments will be made with fine diamond burs and will polished. After that, the same investigator will take in intraoral digital quadrant scan to record the post-adjustment volume of the each crown.

For the qualitative analysis, color-coded maps of the superimposed pre- and post-adjustment .STL files will be used, utilizing metrology software (Geomagic, 3DSystems). The primary outcome measure will be the volumetric measurement (mm3) of occlusal adjustment amount of the tested 3D printed restorations. The color codes will be standardized in every evaluation, and the occlusal views of color-coded maps will be evaluated by two investigators independently. Less than 0.3 mm differences which were presented in green and yellow, are going to be considered clinically as irrelevant. Meanwhile, turquoise (0.3-04mm), dark blue (0.4-0.5 mm), and red (>0.5 mm) will be taken into consideration for the evaluation. The investigators will rate the adjustment amount 0-4 scores based on the adjustment surface, and the geometrical characteristics of the adjustment. Grade 4 adjustments will be considered to require renewal of the restoration due to a change in the anatomical contour of the reconstructions, whereas Grade 0 will be considered as perfect.

Inclusion criteria Age > 18 years old Absence of painful temporomandibular disorder Presence of natural opposing teeth Presence of a stable maximum intercuspation relationship Exclusion criteria Pain in orofacial region Visible periapical lesion < Class II mobility

Statistical Analysis The descriptive statistics will be given as mean (standard deviation) and median [first and third quartiles] for continuous variables, while frequency and percentages will be given for categorical variables. The 2 × 2 cross-table variance analyses and Greenhouse Geisser corrections will be tested for the carry-over effect. The two dependent and independent variables will be compared via the Wilcoxon and Mann-Whitney U tests, respectively. For the 2 × 2 crossover design, repeated measure ANOVA will be implemented. The Wilcoxon test analyzed the operator and patient preferences outcomes. Statistical analysis will be performed using a statistical software program (SPSS Statistics, v23.0; IBM Corp, New York, USA). The significance level will set at p<0.05.

Being tested
Artificial intelligence driven registration, Software based registration
Keywords
Artificial intelligence, Prosthodontics, Automated Design, Occlusion Collusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial intelligence driven registrationOther

    Maxillomandibular relationship is refined using AI driven tools

  • Software based registrationOther

    Maxillomandibular relationship is refined using software based algorithms

Study groups in NCT07295964
Study groupRoleWhat they receive
AI driven designExperimentalThe restoration is designed using an AI driven software
Receives: Other: Artificial intelligence driven registration
AI driven refinement of maxillomandibular relatioshipExperimentalThe restoration is design using a maxillomandibular relationship refined by an AI tool
Receives: Other: Artificial intelligence driven registration
Design of a restoration after automated collision correctionExperimentalThe restoration is designed using the maxillomandibular relationship obtained after the use of a software for automated collision correction
Receives: Other: Software based registration
Design of a restoration using the registration without any further refinementActive comparatorThe restoration is designed using the conventional maxillomandibular relationship as it i obtained by the intraoral scanning without further refinement
Receives: Other: Software based registration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of adjustment

    The investigators will rate the adjustment amount 0-4 scores based on the adjustment surface, and the geometrical characteristics of the adjustment. Grade 4 adjustments will be considered to require renewal of the restoration due to a change in the anatomical contour of the reconstructions, whereas Grade 0 will be considered as perfect.

    Measured: Baseline, after the adjustment of the try-in restorations

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start25 Jan 2026 (estimated)
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion25 Jun 2027 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07295964
Sponsor's protocol ID
STUDY3534
Status last verified
Dec 2025
First submitted
9 Jan 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication

Publications

  • Yuzbasioglu E, Kurt H, Turunc R, Bilir H. Comparison of digital and conventional impression techniques: evaluation of patients' perception, treatment comfort, effectiveness and clinical outcomes. BMC Oral Health. 2014 Jan 30;14:10. doi: 10.1186/1472-6831-14-10.

    PubMed 24479892
  • Sakrana AA. In vitro evaluation of the marginal and internal discrepancies of different esthetic restorations. J Appl Oral Sci. 2013 Nov-Dec;21(6):575-80. doi: 10.1590/1679-775720130064.

    PubMed 24473725
  • Kokubo Y, Ohkubo C, Tsumita M, Miyashita A, Vult von Steyern P, Fukushima S. Clinical marginal and internal gaps of Procera AllCeram crowns. J Oral Rehabil. 2005 Jul;32(7):526-30. doi: 10.1111/j.1365-2842.2005.01458.x.

    PubMed 15975133
  • Mai HN, Lee KB, Lee DH. Fit of interim crowns fabricated using photopolymer-jetting 3D printing. J Prosthet Dent. 2017 Aug;118(2):208-215. doi: 10.1016/j.prosdent.2016.10.030. Epub 2017 Jan 12.

    PubMed 28089333
  • van Noort R. The future of dental devices is digital. Dent Mater. 2012 Jan;28(1):3-12. doi: 10.1016/j.dental.2011.10.014. Epub 2011 Nov 26.

    PubMed 22119539
  • Ng J, Ruse D, Wyatt C. A comparison of the marginal fit of crowns fabricated with digital and conventional methods. J Prosthet Dent. 2014 Sep;112(3):555-60. doi: 10.1016/j.prosdent.2013.12.002. Epub 2014 Mar 11.

    PubMed 24630399
  • Delong R, Ko CC, Anderson GC, Hodges JS, Douglas WH. Comparing maximum intercuspal contacts of virtual dental patients and mounted dental casts. J Prosthet Dent. 2002 Dec;88(6):622-30. doi: 10.1067/mpr.2002.129379.

    PubMed 12488856
  • van den Bergh HT, Owen CP, Howes DG. A comparison of different methods and materials for establishing maximal intercuspal position: A clinical study. J Prosthet Dent. 2024 Oct;132(4):749-754. doi: 10.1016/j.prosdent.2022.01.036. Epub 2022 Sep 30.

    PubMed 36184310
  • Morsy N, El Kateb M. Accuracy of intraoral scanners for static virtual articulation: A systematic review and meta-analysis of multiple outcomes. J Prosthet Dent. 2024 Sep;132(3):546-552. doi: 10.1016/j.prosdent.2022.09.005. Epub 2022 Nov 2.

    PubMed 36333175
  • Revilla-Leon M, Gomez-Polo M, Zeitler JM, Barmak AB, Kois JC, Perez-Barquero JA. Does the available interocclusal space influence the accuracy of the maxillomandibular relationship captured with an intraoral scanner? J Prosthet Dent. 2024 Aug;132(2):435-440. doi: 10.1016/j.prosdent.2022.09.004. Epub 2022 Oct 28.

    PubMed 36349566
  • Ries JM, Grunler C, Wichmann M, Matta RE. Three-dimensional analysis of the accuracy of conventional and completely digital interocclusal registration methods. J Prosthet Dent. 2022 Nov;128(5):994-1000. doi: 10.1016/j.prosdent.2021.03.005. Epub 2021 Apr 19.

    PubMed 33888327
  • Abdulateef S, Edher F, Hannam AG, Tobias DL, Wyatt CCL. Clinical accuracy and reproducibility of virtual interocclusal records. J Prosthet Dent. 2020 Dec;124(6):667-673. doi: 10.1016/j.prosdent.2019.11.014. Epub 2020 Feb 1.

    PubMed 32014284
  • Edher F, Hannam AG, Tobias DL, Wyatt CCL. The accuracy of virtual interocclusal registration during intraoral scanning. J Prosthet Dent. 2018 Dec;120(6):904-912. doi: 10.1016/j.prosdent.2018.01.024. Epub 2018 Jun 28.

    PubMed 29961618
  • Yee SHX, Esguerra RJ, Chew AAQ, Wong KM, Tan KBC. Three-Dimensional Static Articulation Accuracy of Virtual Models - Part I: System Trueness and Precision. J Prosthodont. 2018 Feb;27(2):129-136. doi: 10.1111/jopr.12723. Epub 2017 Dec 13.

    PubMed 29235202
  • Zimmermann M, Ender A, Attin T, Mehl A. Accuracy of Buccal Scan Procedures for the Registration of Habitual Intercuspation. Oper Dent. 2018 Nov/Dec;43(6):573-580. doi: 10.2341/17-272-C. Epub 2018 Apr 9.

    PubMed 29630481

Questions about this trial

What is this clinical trial studying?

A study testing Artificial intelligence driven registration and Software based registration in people with Restoration Design and Digital Occlusal Collision, 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 22 Dec 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 Ntovas, DDS, MSc (6985122220 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?

Level of adjustment (time frame: Baseline, after the adjustment of the try-in restorations). 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 NCT07295964, which also lists 16 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 22 Dec 2025.

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