Reproducibility of Dental Bite Mark Overlay Analysis Using Digital 3D Models in Adult Participants

NCT07552051 | Recruiting

• 1 other identifier: AP_LMC_SG_OVERLAY-REPRO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the reproducibility and repeatability of a standardized digital overlay protocol used in forensic odontology for bite mark analysis. Bite mark analysis methods have been increasingly questioned due to concerns about their scientific reliability. This study focuses on the methodological evaluation of an overlay generation protocol independently of biological trace interpretation. Thirty adult participants requiring routine dental care involving intraoral scanning will be included. A digital impression of the maxillary dentition will be obtained using a standard intraoral scanner, which is a non-invasive and routine clinical procedure. Digital dental models will be anonymized and processed using dedicated software to generate overlays. Four operators with different levels of expertise will independently perform the overlay procedure at two separate time points. The study will assess intra-operator repeatability and inter-operator reproducibility using quantitative 2D and 3D metrics. The objective is to determine the variability of the protocol and to contribute to the standardization and reliability of overlay-based analyses in forensic dentistry.

Conditions

Forensic Dentistry; Bite Mark Analysis

Outcome Measures

Primary Outcomes (1)

• Intra-operator Reproducibility of Overlay Concordance Measurements

  Agreement between repeated overlay analyses performed by the same operator on the same digital maxillary model across two measurement sessions

  Baseline and Day 7 (±2 days)

Secondary Outcomes (4)

• Inter-operator Reproducibility of Overlay Concordance Measurements

  Baseline and Day 7 (±2 days)

• Distance Between Point Clouds in 3D Overlay Analysis

  Baseline and Day 7 (±2 days)

• Surface Overlap in Digital Overlay Analysis

  Baseline and Day 7 (±2 days)

• Influence of Operator Expertise on Overlay Reproducibility

  Baseline and Day 7 (±2 days)

Study Arms (1)

Participants undergoing digital dental model analysis

Single cohort of adult participants undergoing a single intraoral digital scan. Digital models are subsequently analysed by four independent operators at two separate time points (T1 and T2) to assess intra- and inter-operator reproducibility.

Other: 3D Digital Model Overlay Analysis

Interventions

3D Digital Model Overlay Analysis OTHER

Standardized overlay protocol applied to digital dental models (STL/PLY files). Each model is analysed twice by each of four operators at two separate time points (T1 and T2) to assess intra- and inter-operator reproducibility.

Participants undergoing digital dental model analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants recruited among patients attending a dental clinic for routine care requiring intraoral optical scanning.

You may qualify if:

• Age ≥18 years
• Patients requiring dental care including intraoral optical scan
• Able to understand the study and provide informed consent
• Sufficient dentition allowing usable maxillary scan

You may not qualify if:

• Age \<18 years
• Individuals under legal protection (guardianship or curatorship)
• Oral conditions preventing intraoral scanning
• Refusal to participate
• Completely edentulous patients
• Partially edentulous patients (\>8 missing maxillary teeth)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes-Department of Dentistry

Nantes, Nantes, 44000, France

RECRUITING

Central Study Contacts

Lise Malfroy-Camine, MD, PhD

CONTACT

+33 6 76 87 10 79; lise.malfroy@gmail.com

Alexandra Poinas, PhD

CONTACT

+33 2 53 48 28 57; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

FR (1)