Oral Health and Wilson's Disease: SOMAWI

Last updated: October 10, 2024
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Wilson's Disease

Kidney Failure

Treatment

Thorough dental examination

Questionnaire OHIP-14

Saliva samples

Clinical Study ID

NCT05444127
APS_2022_5
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 dentalpanoramic imaging, outside of an emergency context or treatmentfollow-up/maintenance

Exclusion

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 zincsupplementation

  • Patient wearing removable prostheses with zinc-enriched prosthetic adhesives (Fixodent ProPlus®)

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Thorough dental examination
Phase:
Study Start date:
May 17, 2023
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Hopital Charles Foix

    Ivry-sur-Seine, 94200
    France

    Site Not Available

  • Hôpital Charles Foix

    Ivry-sur-Seine, 94200
    France

    Site Not Available

  • Fondation Adolphe de Rothschild

    Paris 19, 75019
    France

    Active - Recruiting

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