Oral Health and Wilson's Disease: SOMAWI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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®)
结局指标
主要结局
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)
时间窗: inclusion visit
The index is obtained from clinical examination and panoramic dental imaging
次要结局
未报告次要终点