Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05444127

Oral Health and Wilson's Disease: SOMAWI

Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-17

150

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on patients with Wilson disease, a condition affecting copper metabolism, and aims to compare oral health between those with hepatic and neurological forms of the disease and a control group without Wilson disease. It highlights that patients with Wilson disease often have poorer dental and periodontal health and a lower oral quality of life. Neurological patients may have more difficulty with jaw function, and treatments for Wilson disease can cause oral mucosa lesions. The study is observational and involves patients and controls undergoing dental health assessments. Participants include patients diagnosed with Wilson disease in either hepatic or neurological forms, as well as control individuals attending routine dental consultations outside emergency or treatment follow-up contexts. The study evaluates dental health using the CAOD index, which measures the severity of caries by counting decayed, absent, and filled permanent teeth. Data collection involves clinical dental exams, panoramic dental imaging, saliva sample collection, and an oral quality of life questionnaire called OHIP-14. During the study, participants undergo a detailed dental examination and provide saliva samples to assess copper levels, which may indicate treatment effectiveness. Controls complete the same oral exams and questionnaires to allow comparison. The primary outcome is the CAOD index score measured at the inclusion visit. The study monitors oral health differences among groups to better understand the impact of Wilson disease on dental conditions. Participation involves one visit with clinical, imaging, and questionnaire assessments.

CONDITIONS

Brief Title

Oral Health and Wilson's Disease: SOMAWI

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Express consent to participate in the study
  • Member of or beneficiary of a social security scheme
  • For cases: Affected by Wilson's disease
  • For controls: Attending a first routine dental consultation with panoramic dental imaging, outside of emergency or follow-up treatment contexts
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding women
  • Severe psychiatric disorders with behavioral disorders
  • For cases: hepatic or neurological decompensation
  • For cases: liver transplant patient
  • For controls: presence of hepatic or neurological disease
  • For controls: taking dietary supplements enriched with copper or zinc or zinc supplementation
  • For controls: wearing removable prostheses with zinc-enriched prosthetic adhesives (Fixodent ProPlus�ae)

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.

Diagnostic Evaluation

Duration - 1 day

Participants undergo a thorough dental examination including panoramic dental imaging and saliva sample collection. They also complete an oral quality of life questionnaire (OHIP-14).

1 visit (in-person)

Trial Site Locations

Total: 3 locations

1

Hopital Charles Foix

Ivry-sur-Seine, France, 94200

Active, Not Recruiting

2

Hôpital Charles Foix

Ivry-sur-Seine, France, 94200

Active, Not Recruiting

3

Fondation Adolphe de Rothschild

Paris, France, 75019

Actively Recruiting

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Research Team

A

Amélie YAVCHITZ

A

Aurélia POUJOIS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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