Comparing oral health in Wilson's disease patients and healthy controls
Official title: Oral Health and Wilson's Disease: SOMAWI
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT05444127 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 2 sites (Ivry-sur-Seine and 1 other locations) |
| Status | Recruiting |
| Started | May 17, 2023 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT05444127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Wilson's disease and those undergoing routine dental consultations.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hopital Charles Foix
Ivry-sur-Seine, France Recruiting -
Fondation Adolphe de Rothschild
Paris, France Recruiting
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PM577a: a one-time gene-editing therapy for Wilson disease
This study tests PM577a, a gene-editing treatment, to see if it is safe and may help people with Wilson disease who have a p.H1069Q ATP7B mutation.
-
Best timing for 24-hour urine copper after a brief treatment break
This will see if a 24-hour urine copper test taken after a short, supervised pause in treatment reflects body copper levels in stable Wilson disease patients.
-
Renal Involvement in Wilson's Disease
This study tests how Wilson's disease affects the kidneys and who might be at risk for kidney problems.
-
Skin effects of D-penicillamine in people with Wilson disease
This project will use silicone molds and confocal imaging to see if D-penicillamine changes skin elasticity in people with Wilson disease compared with matched healthy volunteers.
-
Evaluating LY-M003 Injection for Wilson Disease
This study is testing a new gene therapy called LY-M003 to see if it is safe and effective for people with Wilson Disease.
-
Registry for Rare Diseases
This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.