Oral Health and Wilson's Disease: SOMAWI

NCT ID: NCT05444127

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-17

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Wilson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

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

Saliva samples

Intervention Type 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.

Questionnaire OHIP-14

Intervention Type 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.

Thorough dental examination

Intervention Type 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.

controls

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

Questionnaire OHIP-14

Intervention Type 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.

Thorough dental examination

Intervention Type 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.

Interventions

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Saliva 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.

Intervention Type OTHER

Questionnaire 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.

Intervention Type OTHER

Thorough 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.

Intervention Type OTHER

Eligibility Criteria

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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®)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marjolaine GOSSET

Role: STUDY_DIRECTOR

Hopital Charles Foix

Locations

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Hopital Charles Foix

Ivry-sur-Seine, , France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Charles Foix

Ivry-sur-Seine, , France

Site Status ACTIVE_NOT_RECRUITING

Fondation Adolphe de Rothschild

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amélie YAVCHITZ

Role: CONTACT

01 48 03 64 54

Aurélia POUJOIS

Role: CONTACT

01 48 30 66 56

Facility Contacts

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Aurélia Poujois

Role: primary

0148036656

Other Identifiers

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APS_2022_5

Identifier Type: -

Identifier Source: org_study_id