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Oral Health and Wilson's Disease: SOMAWI

Oral Health and Wilson's Disease: SOMAWI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05444127
Acronym
SOMAWI
Enrollment
150
Registered
2022-07-05
Start date
2023-05-17
Completion date
2026-10-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wilson Disease

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.

Interventions

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.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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®)

Design outcomes

Primary

MeasureTime frameDescription
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 visitThe index is obtained from clinical examination and panoramic dental imaging

Countries

France

Contacts

Primary ContactAmélie YAVCHITZ
ayavhitz@for.paris01 48 03 64 54
Backup ContactAurélia POUJOIS
apoujois@for.paris01 48 30 66 56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026