Oral Health and Wilson's Disease: SOMAWI

Обзор

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.

Подробное описание

The comparaison between the three groups is based on evaluation criteria wich is CAOD index of caries severity (developed by Klein and Palmer in 1940) counting the number of permanent teeth with caries (evolving to include non-cavitary caries) (C), absent due to caries (A) and filled (O) 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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• 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) [Срок оценки: inclusion visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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®)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 3 центра

• Hopital Charles Foix — Ivry-sur-Seine
• Hôpital Charles Foix — Ivry-sur-Seine
• Fondation Adolphe de Rothschild — Paris

Идентификаторы

NCT: NCT05444127 · APS_2022_5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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