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

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon

Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU de Besançon
      • Bron, France, 69678
        • CH Le Vinatier
      • Brumath, France, 67173
        • Chs Epsan
      • Chambéry, France, 73011
        • CHS de la Savoie
      • Dijon, France, 21079
        • CHU de Dijon
      • Dijon, France, 21000
        • CH La Chartreuse
      • Dole, France, 39108
        • CHS du Jura
      • Limoges, France, 87025
        • CH Esquirol
      • Metz, France, 57073
        • CH de Jury
      • Novillars, France, 25220
        • CH de Novillars
      • Saint-Rémy, France, 70160
        • CH de Saint-Rémy et Nord Franche Comté
      • Semur-en-Auxois, France, 21140
        • CH de Semur en Auxois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Dental care education program
Dental care education program
Placebo Comparator: Surveillance
Other: Surveillance
Surveillance

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

October 5, 2020

Study Completion (Actual)

October 5, 2020

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimated)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENIS PHRC I 2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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