Oral Health and Wilson's Disease: SOMAWI

Fondation Ophtalmologique Adolphe de Rothschild

Status: Enrolling

Conditions: Wilson Disease

Treatments: Other: Saliva samples; Other: Questionnaire OHIP-14; Other: Thorough dental examination

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05444127

APS_2022_5

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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®)

Trial design

150 participants in 2 patient groups

Cases

Description:

patients with hepatic form of Wilson disease and those with neurological form

Treatment:

Other: Thorough dental examination

Other: Questionnaire OHIP-14

Other: Saliva samples

controls

Description:

control population consulting in routine dental with panoramic dental imaging, outside of an emergency context

Treatment:

Other: Thorough dental examination

Other: Questionnaire OHIP-14