Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here