Clinical trial NCT02512367: Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.
Official title: Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of patients with a Community Peridontal Index (CPI) ≥3
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besançon
city: Bron
country: France
facility: CH Le Vinatier
city: Brumath
country: France
facility: Chs Epsan
city: Chambery
country: France
facility: CHS de la Savoie
city: Dijon
country: France
facility: CH La Chartreuse
city: Dijon
country: France
facility: CHU de DIJON
city: Dole
country: France
facility: CHS du Jura
city: Limoges
country: France
facility: CH Esquirol
city: Metz
country: France
facility: CH de Jury
city: Novillars
country: France
facility: CH de Novillars
city: Saint Rémy
country: France
facility: CH de Saint-Rémy et Nord Franche Comté
city: Semur en Auxois
country: France
facility: CH de Semur en Auxois
Study officials:
References:
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.