Evaluate the Efficacy of a Global Dental Health Promotion... | NCT02512367

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of inclusion

Expanded Access Info

Start Date

Apr 20, 2017Actual

Primary Completion Date

Oct 5, 2020Actual

Completion Date

Oct 5, 2020Actual

First Submitted Date

Jul 29, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Other: Dental care education program
Surveillance	Placebo Comparator		Other: Surveillance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental care education program	Other	Dental care education program	Intervention

Measure	Description	Time Frame
Proportion of patients with a Community Peridontal Index (CPI) ≥3		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besançon		Besançon		25000	France
CH Le Vinatier

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37444782	Result	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.
27757142	Derived

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders