Oral Health and Wilson's Disease: SOMAWI

NCT05444127 | Recruiting

• 1 other identifier: APS_2022_5
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Wilson Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  The index is obtained from clinical examination and panoramic dental imaging

  inclusion visit

Study Arms (2)

Cases

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

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

controls

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

Other: Questionnaire OHIP-14; Other: Thorough dental examination

Interventions

Saliva samples OTHER

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.

Cases

Questionnaire OHIP-14 OTHER

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.

Cases; controls

Thorough dental examination OTHER

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.

Cases; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The recruitment of Wilson patients will be done in the coordinating center of the CRMR Wilson at the Fondation A de Rothschild Hospital. Control patients matched in age and sex will be identified among patients consulting in the oral medicine department of Charles Foix Hospital. Posters will be placed in the waiting room to inform patients of the existence of the study and promote recruitment.

You may qualify if:

• 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

You may not qualify if:

• 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®)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (3)

Hopital Charles Foix

Ivry-sur-Seine, 94200, France

ACTIVE NOT RECRUITING

Hôpital Charles Foix

Ivry-sur-Seine, 94200, France

ACTIVE NOT RECRUITING

Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Hepatolenticular Degeneration

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marjolaine GOSSET

  Hopital Charles Foix

  STUDY DIRECTOR

Central Study Contacts

Amélie YAVCHITZ

CONTACT

01 48 03 64 54; ayavhitz@for.paris

Aurélia POUJOIS

CONTACT

01 48 30 66 56; apoujois@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: May 17, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

FR (3)