Actively Recruiting

Age: 8Years - 55Years
All Genders
NCT04704089

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-03

80

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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
  • Having one of the following enamel anomalies: amelogenesis imperfecta, dental fluorosis, or molar incisor hypomineralization
  • Provided informed consent or non-opposition from adult or parental representative
  • For witnesses: age 8 to 55 years, no tooth structure anomalies, no tooth discoloration, and no cavities
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Individuals under legal guardianship or curators
  • Minors who oppose participation
  • Enamel anomalies only on molars (spectrophotometer only images anterior teeth)
  • Other types of enamel hypomineralization (post-eruptive, traumatic, infectious, idiopathic)
  • History of radiotherapy or chemotherapy causing dental damage
  • Presence of systemic diseases, haemochromatosis, or porphyria
  • Taking medications that affect tooth color
  • Witnesses with enamel anomalies or multiple extra teeth (polycarpus)

AI-Screening

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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

CONTACT

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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