NCT02512367

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

July 29, 2015

Last Update Submit

February 5, 2026

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a Community Peridontal Index (CPI) ≥3

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Dental care education program

Surveillance

PLACEBO COMPARATOR
Other: Surveillance

Interventions

Dental care education programOTHER

Dental care education program

Intervention
SurveillanceOTHER

Surveillance

Surveillance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU de Besançon

Besançon, 25000, France

Location

CH Le Vinatier

Bron, 69678, France

Location

Chs Epsan

Brumath, 67173, France

Location

CHS de la Savoie

Chambéry, 73011, France

Location

CH La Chartreuse

Dijon, 21000, France

Location

CHU de DIJON

Dijon, 21079, France

Location

CHS du Jura

Dole, 39108, France

Location

CH Esquirol

Limoges, 87025, France

Location

CH de Jury

Metz, 57073, France

Location

CH de Novillars

Novillars, 25220, France

Location

CH de Saint-Rémy et Nord Franche Comté

Saint-Rémy, 70160, France

Location

CH de Semur en Auxois

Semur-en-Auxois, 21140, France

Location

Related Publications (2)

  • Denis F, Rat C, Cros L, Bertaud V, El-Hage W, Jonval L, Soudry-Faure A. Effectiveness of a Therapeutic Educational Oral Health Program for Persons with Schizophrenia: A Cluster Randomized Controlled Trial and Qualitative Approach. Healthcare (Basel). 2023 Jul 5;11(13):1947. doi: 10.3390/healthcare11131947.

    PMID: 37444782RESULT

  • 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.

    PMID: 27757142DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

July 30, 2015

Study Start

April 20, 2017

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(12)