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Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects

NCT04704089 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-07-03

No results posted yet for this study

Summary

The study focuses on the analysis of enamel defects grouping together hypomineralization and hypoplasia. It focuses on 3 very characteristic enamel pathologies that are most often encountered in dental consultations: Molar Incisor Hypomineralization (MIH), dental fluorosis (FD) and amelogenesis imperfecta (AI). The research focuses on the use of a spectrophotometer for measuring tooth colors: the Zfx SpectroShade® (MHT) and its software as a means of early diagnosis of pre-eruptive enamel abnormalities. The main objective of the study is to analyze the color parameters of teeth affected with one of the 3 enamel abnormalities for use of the spectrophotometer as a non-invasive diagnostic tool for enamel defects.

The secondary objective is focused on the biological, structural and physicochemical characterizations of these different enamel pathologies from extracted teeth or enamel biopsies that must be ground to achieve a restoration.

Conditions

  • Amelogenesis Imperfecta
  • Dental Fluoroses
  • Hypomineralization Molar Incisor

Interventions

OTHER

spectrophotometer

* Calibration of the spectrophotometer (calibration of white and green color on the provided support), * Placing the patient or witness in the chair, * Placement of intraoral retractors, * Photographs of the dental arch in occlusion as well as slightly open mouth to visualize the mandibular incisors, * If MIH is suspected, occlusal images of the occlusal surfaces of the first molars will be taken with the help of a dental mirror, * Shooting with the spectrophotometer centered on each of the teeth of interest in the anterior sector with verification of the good quality of the shot according to the axis (validated in green on the camera), * Backup of images with coded identification number

OTHER

Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses

* Chemical analysis of enamel mineral. * Techniques of spectrometry and spectroscopy (Raman and FTIR) * Atomic Probe Tomography and Protein Mass Spectrometry (ICP-MS).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2026-04-18
Completion
2026-04-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704089 on ClinicalTrials.gov