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Recruiting NCT07552051

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

Observational Forensic Dentistry Bite Mark Analysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D Digital Model Overlay Analysis.
Who it may be relevant to
Registry conditions: Forensic Dentistry, Bite Mark Analysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Reproducibility and Repeatability of Digital Overlay Techniques in Bite Mark Morphological Analysis: An Observational Study Using 3D Dental Models

Overview

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.

Detailed description

This is a prospective methodological study designed to evaluate the reproducibility and repeatability of a standardized digital overlay protocol used in forensic odontology.

Background:

Bite mark analysis has been increasingly challenged due to concerns regarding its scientific validity and reliability. In this context, there is a need to assess the methodological robustness of tools used in this field, particularly digital overlay techniques used for comparison purposes.

Objectives:

The primary objective is to assess intra-operator repeatability and inter-operator reproducibility of a standardized overlay generation protocol. Secondary objectives include evaluating the influence of operator expertise and testing quantitative metrics for overlay comparison.

Methods:

Thirty adult participants undergoing routine dental care involving intraoral scanning will be recruited. Participation involves a single, non-invasive intraoral scan of the maxillary dentition, performed using a standard optical scanner.

Digital dental models will be anonymized and exported in STL and PLY formats. A standardized overlay protocol will then be applied using CloudCompare and complementary image processing software.

Four operators with different levels of expertise will independently generate overlays from each model at two separate time points (T1 and T2), spaced by several days, in order to assess repeatability and reproducibility.

Outcome Measures:

Quantitative analysis will be performed using 2D and 3D metrics, including distances between point clouds, root mean square deviation (RMS), and surface overlap measurements.

Data Management:

Only anonymized digital models and limited demographic data (age and sex) will be collected. Data will be stored on secure systems with restricted access and will not be transferred outside the European Union.

Ethics:

The study involves minimal risk, as intraoral scanning is a routine, non-invasive procedure. No biological samples are collected, and no additional interventions are performed beyond standard care.

Significance:

This study aims to provide objective data on the variability of overlay generation methods and to contribute to the standardization and scientific reliability of forensic dental analyses.

Interventions

  • Other 3D Digital Model Overlay Analysis
    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.

Primary outcome measures

  • Intra-operator Reproducibility of Overlay Concordance Measurements [Time frame: Baseline and Day 7 (±2 days)]
Secondary outcome measures (4)
  • Inter-operator Reproducibility of Overlay Concordance Measurements [Time frame: Baseline and Day 7 (±2 days)]
  • Distance Between Point Clouds in 3D Overlay Analysis [Time frame: Baseline and Day 7 (±2 days)]
  • Surface Overlap in Digital Overlay Analysis [Time frame: Baseline and Day 7 (±2 days)]
  • Influence of Operator Expertise on Overlay Reproducibility [Time frame: Baseline and Day 7 (±2 days)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU Nantes-Department of Dentistry — Nantes

Identifiers

NCT: NCT07552051 · AP_LMC_SG_OVERLAY-REPRO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗