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Trial record 1 of 1 for:    NCT02512367
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Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia. (EBENE)

This study is not yet open for participant recruitment.
Verified June 2015 by Centre Hospitalier Universitaire Dijon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02512367
First Posted: July 30, 2015
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose

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 Intervention
Schizophrenia Other: Dental care education program Other: Surveillance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Proportion of patients with a Community Peridontal Index (CPI) ≥3 [ Time Frame: 6 months ]

Estimated Enrollment: 230
Study Start Date: January 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: Dental care education program
Placebo Comparator: Surveillance Other: Surveillance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (Teaching or non-teaching hospital)
  • In-patients or out-patients
  • Older than 18 years.
  • who have provided written informed consent to take part in the study

Exclusion Criteria:

  • Patients who are unstable from a psychiatric poit of view or who suffer from delirium.
  • Patients under forced hospitalization
  • Patients with no teeth
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512367


Contacts
Contact: Frédéric DENIS 3 80 42 56 59 ext +33 frederic.denis@chs-chartreuse.fr

Locations
France
CHU de Besançon Not yet recruiting
Besancon, France, 25000
Contact: Pierre VANDEL    3 81 66 82 34 ext +33      
CH Le Vinatier Not yet recruiting
Bron, France, 69678
Contact: Eric BORY    4 37 91 54 98 ext +33      
Chs Epsan Not yet recruiting
Brumath, France, 67173
Contact: Charles Louis KEL    3 88 64 61 00 ext +33      
CHS de la Savoie Not yet recruiting
Chambery, France, 73011
Contact: Anne COUTELOU    4 79 60 32 48 ext +33      
CH La Chartreuse Not yet recruiting
Dijon, France, 21000
Contact: Jean-Pierre CAPITAIN    3 80 42 52 35 ext +33      
CHU de DIJON Not yet recruiting
Dijon, France, 21079
Contact: Benoît TROJAK    3 80 29 30 31 ext +33    benoit.trojak@chu-dijon.fr   
CHS du Jura Not yet recruiting
Dole, France, 39108
Contact: Virgile MAGNIN-FEYSOT    3 84 82 97 97 ext +33      
CH Esquirol Not yet recruiting
Limoges, France, 87025
Contact: Danièle BOURLOT    5 55 43 12 30 ext +33      
CH de Jury Not yet recruiting
Metz, France, 57073
Contact: Eric CLAUDOT    3 87 56 39 47 ext +33      
CH de Novillars Not yet recruiting
Novillars, France, 25220
Contact: Céline ROYO    3 80 60 58 25 ext +33      
CH de Saint-Rémy et Nord Franche Comté Not yet recruiting
Saint Rémy, France, 70160
Contact: Sylvain LEGAIN    3 84 57 42 70 ext +33      
CH de Semur en Auxois Not yet recruiting
Semur en Auxois, France, 21140
Contact: Thomas WALLENHORST    3 80 89 64 64 ext +33      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02512367     History of Changes
Other Study ID Numbers: DENIS PHRC I 2014
First Submitted: July 29, 2015
First Posted: July 30, 2015
Last Update Posted: July 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders