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Идёт набор NCT07552051

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

Наблюдательное Forensic Dentistry Bite Mark Analysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 3D Digital Model Overlay Analysis.
Кому может быть актуально
Состояния в реестре: Forensic Dentistry, Bite Mark Analysis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Intra-operator Reproducibility of Overlay Concordance Measurements [Срок оценки: Baseline and Day 7 (±2 days)]
Вторичные конечные точки (4)
  • Inter-operator Reproducibility of Overlay Concordance Measurements [Срок оценки: Baseline and Day 7 (±2 days)]
  • Distance Between Point Clouds in 3D Overlay Analysis [Срок оценки: Baseline and Day 7 (±2 days)]
  • Surface Overlap in Digital Overlay Analysis [Срок оценки: Baseline and Day 7 (±2 days)]
  • Influence of Operator Expertise on Overlay Reproducibility [Срок оценки: Baseline and Day 7 (±2 days)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • CHU Nantes-Department of Dentistry — Nantes

Идентификаторы

NCT: NCT07552051 · AP_LMC_SG_OVERLAY-REPRO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗