Wilson Disease Clinical Trial
— SOMAWIOfficial title:
Oral Health and Wilson's Disease: SOMAWI
NCT number | NCT05444127 |
Other study ID # | APS_2022_5 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 17, 2023 |
Est. completion date | July 2024 |
Patients with Wilson disease have poorer dental and periodontal health and a have lower oral quality of life than control patients. Patients with a neurological form would also more frequently present limitations in the function of the masticatory apparatus. Systemic treatments for Wilson disease are associated with lesions of the oral mucosa. Analysis of copper level in saliva could testify to the effectiveness of copper depletion in treated patients The main objective is to compare the state of dental health between: patients with Wilson disease in the hepatic form and patients with the neurological form, and a population of controls.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ProPlusĀ®) |
Country | Name | City | State |
---|---|---|---|
France | Hopital Charles Foix | Ivry-sur-Seine | |
France | Hôpital Charles Foix | Ivry-sur-Seine | |
France | Fondation Adolphe de Rothschild | Paris 19 |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CAOD index of the severity of the caries impairment counting the number of permanent teeth decayed in an individual. The maximum score is 28 (third molars are not taken into account) | The index is obtained from clinical examination and panoramic dental imaging | inclusion visit |
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