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

Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02512367

Acronym

EBENE

Enrollment

Registered

2015-07-30

Start date

2017-04-20

Completion date

2020-10-05

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

OTHERDental care education program

Dental care education program

OTHERSurveillance

Surveillance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026