구강 건강과 윌슨병: SOMAWI (SOMAWI)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Amélie YAVCHITZ
- 전화번호: 01 48 03 64 54
- 이메일: ayavhitz@for.paris
연구 연락처 백업
- 이름: Aurélia POUJOIS
- 전화번호: 01 48 30 66 56
- 이메일: apoujois@for.paris
연구 장소
-
-
-
Ivry-sur-Seine, 프랑스, 94200
- 모병
- Hopital Charles Foix
-
연락하다:
- Marjolaine GOSSET
- 전화번호: 01 49 59 48 03
- 이메일: marjolaine.gosset@aphp.fr
-
Paris, 프랑스, 75019
- 모병
- Fondation Adolphe de Rothschild
-
연락하다:
- Aurélia Poujois
- 전화번호: 0148036656
- 이메일: apoujois@for.paris
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
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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®)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cases
patients with hepatic form of Wilson disease and those with neurological form |
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. 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. 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 |
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. 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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)
기간: inclusion visit
|
The index is obtained from clinical examination and panoramic dental imaging |
inclusion visit
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Marjolaine GOSSET, Hopital Charles Foix
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APS_2022_5
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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