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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2020-10-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Dental care education program

Intervention Type OTHER

Dental care education program

Surveillance

Group Type PLACEBO_COMPARATOR

Surveillance

Intervention Type OTHER

Surveillance

Interventions

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Dental care education program

Intervention Type OTHER

Surveillance

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No