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

Brief Title

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

Official Title

Colorimetric Comparison of Email Defects Using Spectrophotometric and Computer Techniques and Biological, Structural and Physico-chemical Analyses of Teeth or Pathological Enamel

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.
    

Detailed Description

      Methodology:

      V1 inclusion visit (D1):

      The subjects will be screened during a consultation carried out as part of the treatment in
      the participating dentistry departments. The inclusion and non-inclusion criteria for
      participants will be verified and the study will be offered to eligible patients and
      controls. The research briefing note will be given and the non-objection of the participants
      (adults and representative (s) of parental authority) will be collected. The investigator
      will then take the photographs and spectrophotometer shots (at least 2 teeth per
      participant).

      V2 follow-up visit (within 2 months of the inclusion visit (D2 to M2)):

      The patients will be reviewed in consultation as part of the treatment for selective grinding
      for dental restoration or extraction (if the tooth (s) is (are) no longer storable). The
      teeth or pathological enamel samples will be recovered and centralized at the Laboratory of
      Oral Molecular Physiopathology.

      Biological, structural and physico-chemical analyzes will be carried out from these samples.

      In order to ensure follow-up of participants, the principal investigator of each center will
      maintain a correspondence table including the participant's identity and his research
      identification number. He will also keep a register of oppositions up to date.

      The subject's opposition or participation will be notified in his medical file. A copy of the
      briefing notes and non-objection forms signed by the dentist will be kept on site with the
      research documents. Minors who become adults during their participation will benefit from
      appropriate information and their non-objection will be collected.

      Primary endpoint Analysis, using the spectrophotometer, of the numerical values of the color
      of the teeth in each of the populations studied (Hereditary amelogenesis imperfecta (AIH),
      dental fluorosis (FD), Hypomineralization Incisors and Molar (MIH) and control).

      For each pathology, the values of these parameters will be compared. Secondary endpoints

        -  Intra-pathology classification according to the severity of each pathology.

        -  Characterization and biological, structural and physicochemical analysis of these
           different pathologies from extracted teeth or enamel biopsy to be ground to achieve a
           restoration.

      Sample analysis The teeth samples will be stored at room temperature in the Oral Molecular
      Physiopathology laboratory in the Research Center.

      During the research, biological, structural and physicochemical analyzes will be carried out
      at the laboratory or in another laboratory in France or abroad. A contract will be
      established upstream of these analyzes with the partner laboratory.

      At the end of the research, samples not destroyed by destructive analysis techniques will be
      embedded in the resin and stored for 10 years before being destroyed. These samples can be
      used for additional analyzes (biological, structural and physico-chemical) according to the
      request of the references for the publication process.
    


Study Type

Observational


Primary Outcome

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.

Secondary Outcome

 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).

Condition

Amelogenesis Imperfecta

Intervention

spectrophotometer

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

80

Start Date

March 1, 2021

Completion Date

May 1, 2023

Primary Completion Date

May 1, 2023

Eligibility Criteria

        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)
      

Gender

All

Ages

8 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

, 06 12 16 88 35, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04704089

Organization ID

APHP190001


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

, , 


Verification Date

December 2020