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RecruitingNCT05444127SOMAWIUpdated Oct 6, 2026

Oral Health and Wilson's Disease: SOMAWI

An observational study in Wilson Disease, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Updated Oct 6, 2026Site recruiting status changedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wilson Disease
03

In context

Hepatolenticular Degeneration

78 studies on the registry are indexed under Hepatolenticular Degeneration; 30 are open to participants now.

This study's planned enrollment of 150 is above the median of 69 across 34 observational studies indexed under Hepatolenticular Degeneration.

Browse Hepatolenticular Degeneration studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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®)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

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

    Other: Saliva samples · Other: Questionnaire OHIP-14 · Other: Thorough dental examination

  • controls

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

    Other: Questionnaire OHIP-14 · Other: Thorough dental examination

Interventions

  • OtherSaliva 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: inclusion visit

07

Study locations

2 of 2 sites recruiting
  • Hopital Charles Foix
    Ivry-sur-Seine, 94200, France
    Recruiting
  • Fondation Adolphe de Rothschild
    Paris, 75019, France
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
1 site removed. Hopital Charles Foix is now Recruiting
Show 1 removed
  • Hôpital Charles Foix · Ivry-sur-Seine, France
Oct 6, 2026
Primary completion
Oct 2026→Aug 2027
Oct 6, 2026
Study completion
Oct 2026→Aug 2027
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    1 site removed. Hopital Charles Foix is now Recruiting
    Show 1 removed
    • Hôpital Charles Foix · Ivry-sur-Seine, France
    Primary completion Oct 2026→Aug 2027
    Study completion Oct 2026→Aug 2027
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05444127
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Jul 5, 2022
Start date
May 17, 2023
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Amélie YAVCHITZ
Contact
ayavhitz@for.paris
01 48 03 64 54
Aurélia POUJOIS
Contact
apoujois@for.paris
01 48 30 66 56
Marjolaine GOSSET
study director · Hopital Charles Foix

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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