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

University Hospital Center (CHU) Dijon Bourgogne

Status: Terminated

Conditions: Schizophrenia

Treatments: Other: Surveillance; Other: Dental care education program

Study type: Interventional

Funder types: Other

Identifiers

NCT02512367

DENIS PHRC I 2014

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Treatment:

Other: Dental care education program

Surveillance

Placebo Comparator group

Treatment:

Other: Surveillance