Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-55
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Major or minor patients with Hereditary Imperfect Amelogenesis Imperfecta (HIA), Dental Fluorosis (DF), Incisor and Molar Hypomineralization (MIH) or Control
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
spectrophotometer
Other intervention* 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
Other intervention* Chemical analysis of enamel mineral. * Techniques of spectrometry and spectroscopy (Raman and FTIR) * Atomic Probe Tomography and Protein Mass Spectrometry (ICP-MS).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: spectrophotometer, and numerical values of tooth color in the populations studied2 interventions
Trial outcomes
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.
Time frame
at the first visit = inclusion visitSecondary outcomes
1
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).
Time frame
at the second visit, 2 months after inclusion visit and after tooth extraction2
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.
Time frame
at the second visit, 2 months after inclusion visit and after tooth extraction3
Physico-chemical characterization by different spectroscopic techniques of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Time frame
at the second visit, 2 months after inclusion visit and after tooth extraction4
Physico-chemical characterization by atomic probe tomography of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Time frame
at the second visit, 2 months after inclusion visit and after tooth extractionSponsors and contacts
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Source ClinicalTrials.gov