Oral Health and Wilson's Disease: SOMAWI

Wilson Disease Clinical Trial

— SOMAWI  

Official title:

Oral Health and Wilson's Disease: SOMAWI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444127
• Other study ID #: APS_2022_5
• Status: Recruiting
• Start date: May 17, 2023
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ
• Phone: 01 48 03 64 54
• Email: ayavhitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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®)

Related Conditions & MeSH terms

• Wilson Disease

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Hopital Charles Foix	Ivry-sur-Seine
France	Hôpital Charles Foix	Ivry-sur-Seine
France	Fondation Adolphe de Rothschild	Paris 19

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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