Oral Health and Wilson's Disease: SOMAWI

Recruiting

• Conditions: Wilson Disease
• Interventions: Other: Saliva samples; Other: Questionnaire OHIP-14; Other: Thorough dental examination

• Registration Number: NCT05444127
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Study Start: 2023-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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®)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Saliva samples	patients with hepatic form of Wilson disease and those with neurological form
Cases	Thorough dental examination	patients with hepatic form of Wilson disease and those with neurological form
controls	Questionnaire OHIP-14	control population consulting in routine dental with panoramic dental imaging, outside of an emergency context
Cases	Questionnaire OHIP-14	patients with hepatic form of Wilson disease and those with neurological form
controls	Thorough dental examination	control population consulting in routine dental with panoramic dental imaging, outside of an emergency context

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (3)

Hôpital Charles Foix; 🇫🇷 Ivry-sur-Seine, France

Fondation Adolphe de Rothschild; 🇫🇷 Paris 19, France

Hopital Charles Foix; 🇫🇷 Ivry-sur-Seine, France