Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04704089 |
| Other study ID # |
APHP190001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
April 18, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Sophia HOUARI, MCU-PH |
| Phone |
06 12 16 88 35 |
| Email |
sophia.houari[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
