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

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Other: Dental care education program; Other: Surveillance

• Registration Number: NCT02512367
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Study Start: 2017-04-20
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dental care education program	-
Surveillance	Surveillance	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a Community Peridontal Index (CPI) ≥3	6 months

Trial Locations

Locations (12)

CHU de DIJON; 🇫🇷 Dijon, France

CH La Chartreuse; 🇫🇷 Dijon, France

CH de Semur en Auxois; 🇫🇷 Semur en Auxois, France

CH Le Vinatier; 🇫🇷 Bron, France

Chs Epsan; 🇫🇷 Brumath, France

CHS du Jura; 🇫🇷 Dole, France

CHS de la Savoie; 🇫🇷 Chambery, France

CHU de Besançon; 🇫🇷 Besancon, 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