Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia. (EBENE)
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dental care education program
Surveillance
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- CHU de Besançon
- CH Le Vinatier
- Chs Epsan
- CHS de la Savoie
- CH La Chartreuse
- CHU de DIJON
- CHS du Jura
- CH Esquirol
- CH de Jury
- CH de Novillars
- CH de Saint-Rémy et Nord Franche Comté
- CH de Semur en Auxois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Surveillance
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with a Community Peridontal Index (CPI) ≥3
Secondary Outcome Measures
Full Information
NCT ID
NCT02512367
First Posted
July 29, 2015
Last Updated
May 18, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02512367
Brief Title
Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.
Acronym
EBENE
Official Title
Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusion
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Surveillance
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Dental care education program
Intervention Description
Dental care education program
Intervention Type
Other
Intervention Name(s)
Surveillance
Intervention Description
Surveillance
Primary Outcome Measure Information:
Title
Proportion of patients with a Community Peridontal Index (CPI) ≥3
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Besançon
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
CH Le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Facility Name
Chs Epsan
City
Brumath
ZIP/Postal Code
67173
Country
France
Facility Name
CHS de la Savoie
City
Chambery
ZIP/Postal Code
73011
Country
France
Facility Name
CH La Chartreuse
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHS du Jura
City
Dole
ZIP/Postal Code
39108
Country
France
Facility Name
CH Esquirol
City
Limoges
ZIP/Postal Code
87025
Country
France
Facility Name
CH de Jury
City
Metz
ZIP/Postal Code
57073
Country
France
Facility Name
CH de Novillars
City
Novillars
ZIP/Postal Code
25220
Country
France
Facility Name
CH de Saint-Rémy et Nord Franche Comté
City
Saint Rémy
ZIP/Postal Code
70160
Country
France
Facility Name
CH de Semur en Auxois
City
Semur en Auxois
ZIP/Postal Code
21140
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27757142
Citation
Denis F, Millot I, Abello N, Carpentier M, Peteuil A, Soudry-Faure A. Study protocol: a cluster randomized controlled trial to assess the effectiveness of a therapeutic educational program in oral health for persons with schizophrenia. Int J Ment Health Syst. 2016 Oct 5;10:65. doi: 10.1186/s13033-016-0096-0. eCollection 2016.
Results Reference
derived
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Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.
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