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

NCT04704089 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2022-07-18

Last updated

2025-07-03

Condition(s) studied

Amelogenesis ImperfectaDental FluorosesHypomineralization Molar Incisor

Investigational drug(s) / intervention(s)

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

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

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).

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.

Eligibility

Sex

ALL

Min age

8 Years

Max age

55 Years

Healthy volunteers

For patients : Inclusion Criteria : 1. Age between 8 and 55 years old 2. Carrier of one of the following 3 quantitative pre-eruptive enamel anomalies : AIH, dental fluorosis or MIH 3. Information and collection of the non-opposition of the adult patient or of the representative(s) of parental authority present for the minors. Criteria for non-inclusion : 1. Pregnant or breastfeeding woman 2. Under guardianship or curators 3. Opposition of the minor patient 4. Presenting pre-eruptive anomalies only on the molars (the spectrophotometer can only take pictures of the anterior dental sector (incisors and canines)). 5. Other types of hypomineralization (post-eruptive, of traumatic or infectious origin, idiopathic). 6. Having undergone radiotherapy or chemotherapy inducing dental and periodontal damage. 7. Having systemic abnormalities (unbalanced diseases), haemochromatosis, porphyria 8. Under medication likely to disturb the coloring of the teeth For witnesses : Inclusion Criteria : 1. Age between 8 and 55 years old 2. Information and collection of the non-opposition of the adult witness or of the representative(s) of parental authority present for the minors. 3. Free of any anomaly of tooth structure, exogenous dyschromia and carious lesions. Criteria for non-inclusion : 1. Pregnant or breastfeeding woman 2. Under guardianship or curators 3. Opposition of the minor witness 4. Carrier of a quantitative pre-eruptive enamel anomaly 5. Polycarpus (preventing the diagnosis of amyl hypomineralization)

Primary outcome measure(s)

analyze the color parameters of teeth presenting one of the 3 enamel anomalies in order to use the spectrophotometer as a non-invasive diagnostic tool for enamel dyschromia. — at the first visit = inclusion visit

Trial sites (1)

Facility	City	Region	Status
Service d'odontologie, Hôpital Pitié-Salpêtrière	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04704089 on ClinicalTrials.gov ↗ ← All trials in France