Clinical trial NCT05444127: Oral Health and Wilson's Disease: SOMAWI
Official title: Oral Health and Wilson's Disease: SOMAWI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-07-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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®)

Primary outcomes:
measure: 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)
timeFrame: inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Hopital Charles Foix
city: Ivry-sur-Seine
country: France
facility: Hôpital Charles Foix
city: Paris 19
country: France
facility: Fondation Adolphe de Rothschild
Study officials:
affiliation: Hopital Charles Foix
name: Marjolaine GOSSET
role: STUDY_DIRECTOR
References: