RecruitingNCT05444127

Oral Health and Wilson's Disease: SOMAWI


Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrollment

150 participants

Start Date

May 17, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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®)

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Interventions

OTHERSaliva 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.

OTHERQuestionnaire 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.

OTHERThorough 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.


Locations(3)

Hopital Charles Foix

Ivry-sur-Seine, France

Hôpital Charles Foix

Ivry-sur-Seine, France

Fondation Adolphe de Rothschild

Paris, France

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NCT05444127


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