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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Terminated
CT.gov ID
NCT02512367
Collaborator
(none)
79
Enrollment
12
Locations
2
Arms
41.5
Actual Duration (Months)
6.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dental care education program
  • Other: Surveillance
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
Actual Study Start Date :
Apr 20, 2017
Actual Primary Completion Date :
Oct 5, 2020
Actual Study Completion Date :
Oct 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Other: Dental care education program
Dental care education program
Placebo Comparator: Surveillance

Other: Surveillance
Surveillance

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with a Community Peridontal Index (CPI) ≥3 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besancon France 25000
2 CH Le Vinatier Bron France 69678
3 Chs Epsan Brumath France 67173
4 CHS de la Savoie Chambery France 73011
5 CH La Chartreuse Dijon France 21000
6 CHU de DIJON Dijon France 21079
7 CHS du Jura Dole France 39108
8 CH Esquirol Limoges France 87025
9 CH de Jury Metz France 57073
10 CH de Novillars Novillars France 25220
11 CH de Saint-Rémy et Nord Franche Comté Saint Rémy France 70160
12 CH de Semur en Auxois Semur en Auxois France 21140

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02512367
Other Study ID Numbers:
  • DENIS PHRC I 2014
First Posted:
Jul 30, 2015
Last Update Posted:
May 20, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of May 20, 2021