Oral Health and Wilson's Disease: SOMAWI
ConditionWilson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondation Ophtalmologique Adolphe de Rothschild
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patient benefiting from a legal protection measure
Pregnant or breastfeeding women
Severe psychiatric disorders with behavioral disorders
hepatic or neurological decompensation
Trial population
The recruitment of Wilson patients will be done in the coordinating center of the CRMR Wilson at the Fondation A de Rothschild Hospital. Control patients matched in age and sex will be identified among patients consulting in the oral medicine department of Charles Foix Hospital. Posters will be placed in the waiting room to inform patients of the existence of the study and promote recruitment.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Saliva samples
Other interventionA 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
Other interventionA 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
Other interventionA 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Cases3 interventions
Group B: controls2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
inclusion visitSponsors and contacts
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Source ClinicalTrials.gov