Oral Health and Wilson's Disease: SOMAWI

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05444127
Collaborator
(none)
150
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Saliva samples
  • Other: Questionnaire OHIP-14
  • Other: Thorough dental examination

Detailed Description

The comparaison between the tree 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Oral Health and Wilson's Disease: SOMAWI
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Cases

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

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.

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.

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.

controls

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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. CADD 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 visit]

    The index is obtained from clinical examination and panoramic dental imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 ProPlusĀ®)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT05444127
Other Study ID Numbers:
  • APS_2022_5
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022