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

December 16, 2025 updated by: Panagiotis Ntovas, National and Kapodistrian University of Athens

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI driven design
The restoration is designed using an AI driven software
Other: Artificial intelligence driven registration
Maxillomandibular relationship is refined using AI driven tools
Experimental: AI driven refinement of maxillomandibular relatioship
The restoration is design using a maxillomandibular relationship refined by an AI tool
Other: Artificial intelligence driven registration
Maxillomandibular relationship is refined using AI driven tools
Experimental: Design of a restoration after automated collision correction
The restoration is designed using the maxillomandibular relationship obtained after the use of a software for automated collision correction
Other: Software based registration
Maxillomandibular relationship is refined using software based algorithms
Active Comparator: Design of a restoration using the registration without any further refinement
The restoration is designed using the conventional maxillomandibular relationship as it i obtained by the intraoral scanning without further refinement
Other: Software based registration
Maxillomandibular relationship is refined using software based algorithms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of adjustment
Time Frame: Baseline, after the adjustment of the try-in restorations
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.
Baseline, after the adjustment of the try-in restorations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

June 25, 2027

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY3534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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