Orální zdraví a Wilsonova choroba: 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Amélie YAVCHITZ
- Telefonní číslo: 01 48 03 64 54
- E-mail: ayavhitz@for.paris
Studijní záloha kontaktů
- Jméno: Aurélia POUJOIS
- Telefonní číslo: 01 48 30 66 56
- E-mail: apoujois@for.paris
Studijní místa
-
-
-
Ivry-sur-Seine, Francie, 94200
- Nábor
- Hopital Charles Foix
-
Kontakt:
- Marjolaine GOSSET
- Telefonní číslo: 01 49 59 48 03
- E-mail: marjolaine.gosset@aphp.fr
-
Paris, Francie, 75019
- Nábor
- Fondation Adolphe de Rothschild
-
Kontakt:
- Aurélia Poujois
- Telefonní číslo: 0148036656
- E-mail: apoujois@for.paris
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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®)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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)
Časové okno: inclusion visit
|
The index is obtained from clinical examination and panoramic dental imaging |
inclusion visit
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Marjolaine GOSSET, Hopital Charles Foix
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Metabolismus, vrozené chyby
- Genetické choroby, vrozené
- Metabolické choroby
- Nemoci trávicího systému
- Neurodegenerativní onemocnění
- Onemocnění jater
- Poruchy pohybu
- Heredodegenerativní poruchy, nervový systém
- Bazální gangliové choroby
- Nemoci mozku, metabolické, vrozené
- Nemoci mozku, Metabolické
- Metabolismus kovů, vrozené chyby
- Vrozené, dědičné a neonatální nemoci a abnormality
- Nutriční a metabolické nemoci
- Hepatolentikulární degenerace
Další identifikační čísla studie
- APS_2022_5
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