Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.

Schizophrenia Clinical Trial

— EBENE  

Official title:

Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02512367
• Other study ID #: DENIS PHRC I 2014
• Status: Terminated
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: October 5, 2020

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. The aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention.

This is an interventional trial, randomized in clusters. The participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance).

For each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. The follow-up will evaluate dental health and quality of life.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM V)

• Managed at a specialized establishment

• Older than 18 years.

• who have provided written informed consent to take part in the study

Exclusion Criteria:

• Fully hospitalized patients

• Patients who are unstable from a psychiatric poit of view or who suffer from delirium.

• Subjects with less than one incisor, canine, premolar and molar on each hemi-arch

• Patients with a risk of infectious endocarditis or a major risk of superinfection

• Patients on long-term treatment with antibiotics (Impact of antibiotherapy on oral flora)

• Patients treated with chemotherapy

• Pregnant or breastfeeding women

• Patients without National Health Insurance cover.

• Poor written and/or oral comprehension of the French language

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Dental care education program
Dental care education program
• Surveillance
Surveillance

Locations

Country	Name	City	State
France	CHU de Besançon	Besancon
France	CH Le Vinatier	Bron
France	Chs Epsan	Brumath
France	CHS de la Savoie	Chambery
France	CH La Chartreuse	Dijon
France	CHU de DIJON	Dijon
France	CHS du Jura	Dole
France	CH Esquirol	Limoges
France	CH de Jury	Metz
France	CH de Novillars	Novillars
France	CH de Saint-Rémy et Nord Franche Comté	Saint Rémy
France	CH de Semur en Auxois	Semur en Auxois

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a Community Peridontal Index (CPI) =3		6 months