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Oral Health and Wilson's Disease: SOMAWI

Recruitingn/aAges 18 Years - anyAllFondation Ophtalmologique Adolphe de Rothschild
NCT05444127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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®)
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What it tests

  • Saliva samples
  • Questionnaire OHIP-14
  • Thorough dental examination
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Where

2 sites
Hopital Charles Foix
Ivry-sur-Seine, France
Fondation Adolphe de Rothschild
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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