Comparing oral health in Wilson's disease patients and healthy controls
Oral Health and Wilson's Disease: SOMAWI
Fondation Ophtalmologique Adolphe de Rothschild · NCT05444127
This study looks at the dental health of people with Wilson's disease compared to healthy individuals to see how the condition affects their teeth and mouth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild (network) |
| Locations | 3 sites (Ivry-sur-Seine and 2 other locations) |
| Trial ID | NCT05444127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the dental health of patients with Wilson's disease, comparing those with hepatic and neurological forms to a control group. It will utilize the CAOD index to assess caries severity through clinical examinations and panoramic dental imaging. Additionally, saliva samples will be analyzed to measure copper levels, which may indicate the effectiveness of treatment. The study seeks to understand the impact of Wilson's disease on oral quality of life and dental health.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Wilson's disease and those undergoing routine dental consultations.
Not a fit: Patients with severe psychiatric disorders, liver transplant recipients, or those with acute decompensation of Wilson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of oral health challenges faced by patients with Wilson's disease and inform better dental care strategies.
How similar studies have performed: While there is limited research specifically on oral health in Wilson's disease, studies on related conditions have shown the importance of dental health assessments, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: Benefiting from a first routine dental consultation with dental panoramic imaging, outside of an emergency context or treatment follow-up/maintenance Exclusion Criteria: * Patient benefiting from a legal protection measure * Pregnant or breastfeeding women * Severe psychiatric disorders with behavioral disorders * For cases: * hepatic or neurological decompensation * liver transplant patient * For witnesses: * Patient with hepatic or neurological disease * Patient taking dietary supplements enriched with copper or zinc or zinc supplementation * Patient wearing removable prostheses with zinc-enriched prosthetic adhesives (Fixodent ProPlus®)
Where this trial is running
Ivry-sur-Seine and 2 other locations
- Hopital Charles Foix — Ivry-sur-Seine, France (ACTIVE_NOT_RECRUITING)
- Hôpital Charles Foix — Ivry-sur-Seine, France (ACTIVE_NOT_RECRUITING)
- Fondation Adolphe de Rothschild — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wilson Disease