Actively Recruiting

Age: 8Years - 55Years
All Genders
ID04704089

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

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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

Age: 8Years - 55Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during dental consultation

Monitoring

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

Sample Collection

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

Long-term Monitoring

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

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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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