Actively Recruiting
Colorimetric Comparison of Enamel Defects Using Spectrophotometric and Computer Techniques and Biological, Structural and Physico-chemical Analyses of Teeth or Pathological Enamel
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-03
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying enamel defects that include hypomineralization and hypoplasia, focusing on three common dental conditions: Molar Incisor Hypomineralization (MIH), dental fluorosis, and amelogenesis imperfecta. The study aims to evaluate the use of a spectrophotometer, the Zfx SpectroShade®, to measure tooth color as a non-invasive tool for early diagnosis of these enamel abnormalities. Additionally, biological, structural, and physicochemical characteristics of these enamel pathologies will be analyzed from extracted teeth or enamel biopsies. The study involves two main visits. At the first visit, participants undergo a screening consultation where photographs and spectrophotometer images of at least two teeth are taken. At a follow-up visit within two months, patients requiring dental treatment will have selected teeth extracted or restored, allowing collection of samples for detailed laboratory analysis. These analyses include protein studies, electron microscopy, and various spectroscopic and elemental techniques performed at specialized laboratories. Participants will be monitored with careful documentation and follow-up, including consent and non-opposition forms, especially for minors. Researchers will analyze color parameters of affected teeth using the spectrophotometer and compare these across different enamel disorders. The study also collects extensive data on the biological and physical makeup of enamel abnormalities to support accurate diagnosis and characterization. Samples will be stored securely for up to ten years for possible future research. The total participation involves initial imaging and a follow-up dental procedure within two months.
CONDITIONS
Brief Title
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and 55 years old
- Diagnosed with amelogenesis imperfecta, dental fluorosis, or molar incisor hypomineralization
- Provided informed consent or non-opposition for adults or from parental authorities for minors
- For control participants: age 8 to 55, no tooth structure anomalies, no discoloration or cavities
You will not qualify if you...
- Pregnant or breastfeeding women
- Individuals under guardianship or curatorship
- Minors who oppose participation
- Only molar pre-eruptive anomalies (spectrophotometer measures anterior teeth only)
- Other types of hypomineralization (post-eruptive, traumatic, infectious, idiopathic)
- History of radiotherapy or chemotherapy causing dental damage
- Systemic illnesses such as unbalanced diseases, haemochromatosis, porphyria
- Medication that affects tooth color
- Control participants with enamel anomalies or multiple teeth (polycarpus) preventing diagnosis of hypomineralization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during dental consultation
Duration - 1 day
Participants undergo non-invasive color measurement of teeth using a spectrophotometer and photographic imaging.
1 visit (in-person) for spectrophotometer measurements and photographs
Duration - Within 2 months after initial visit
For participants requiring dental restoration or tooth extraction, teeth or enamel samples are collected for biological, structural, and physico-chemical analyses.
1 follow-up visit (in-person) during dental treatment for sample collection
Duration - Ongoing after sample collection
Collected teeth samples are analyzed biologically, structurally, and physico-chemically in specialized laboratories; remaining samples are stored for up to 10 years for possible additional analyses.
No visits required for participants during this stage
Trial Site Locations
Total: 1 location
1
Service d'odontologie, Hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
S
Sophia HOUARI, MCU-PH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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