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

NCT04704089 | Recruiting

• 1 other identifier: APHP190001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colorimetry (MeSH); Amelogenesis Imperfecta (MeSH); Dental Fluorosis (MeSH); Molar-incisor-Hypomineralization (MeSH); Developmental Enamel Defects (MeSH); Shade selection; Dental color matching; Diagnosis (MeSH)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Biological characterization of the proteins of the dental enamel matrix by Western Blot and/or mass spectrometry from samples (extracted teeth or enamel biopsies to be ground during the treatment).

  at the second visit, 2 months after inclusion visit and after tooth extraction

• Ultra-structural characterization under electron microscope and biomechanics by nanoindentation of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.

  at the second visit, 2 months after inclusion visit and after tooth extraction

• Physico-chemical characterization by different spectroscopic techniques of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.

  at the second visit, 2 months after inclusion visit and after tooth extraction

• Physico-chemical characterization by atomic probe tomography of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.

  at the second visit, 2 months after inclusion visit and after tooth extraction

Study Arms (1)

spectrophotometer, and numerical values of tooth color in the populations studied

at the first visit Shooting with Spectrophotometer and at the second visit for all patients except control population: Tooth extraction or restorative treatment Collection of teeth or enamel debris for analysis

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

Interventions

spectrophotometer OTHER

* 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

spectrophotometer, and numerical values of tooth color in the populations studied

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

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

spectrophotometer, and numerical values of tooth color in the populations studied

Eligibility Criteria

• Age: 8 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Major or minor patients with Hereditary Imperfect Amelogenesis Imperfecta (HIA), Dental Fluorosis (DF), Incisor and Molar Hypomineralization (MIH) or Control

You may qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'odontologie, Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Amelogenesis Imperfecta; Fluorosis, Dental; Molar Hypomineralization; Developmental Defects of Enamel; Disease

Interventions

Biological Products; Microscopy, Electron

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dental Enamel Hypomineralization; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Sophia HOUARI, MCU-PH

CONTACT

06 12 16 88 35; sophia.houari@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 11, 2021
• Study Start: July 18, 2022
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

FR (1)