Oral Health and Wilson's Disease: SOMAWI
Condition(s) studied
Investigational drug(s) / intervention(s)
Saliva samples: A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.
Questionnaire OHIP-14: A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.
Thorough dental examination: A saliva sample is added by research for all patients, as well as an oral quality of life questionnaire. For the witnesses, participation also entails the completion of the standardized oral examination (potentially longer than the assessment that would have been carried out as part of the treatment) and the administration of the oral quality of life questionnaire.
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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) — inclusion visit
The index is obtained from clinical examination and panoramic dental imaging
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Hopital Charles Foix | Ivry-sur-Seine | France | Recruiting |
| Fondation Adolphe de Rothschild | Paris | France | Recruiting |
More Fondation Ophtalmologique Adolphe de Rothschild trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05444127 on ClinicalTrials.gov ↗ ← All trials in France