SchizophreniaEBENENCT02512367
Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.
A study testing Dental care education program and Surveillance in people with Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 12 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Dental care education program and Surveillance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 12 sitesFrance
- Study dates
- 20 Apr 2017to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or breastfeeding women
- Patients without National Health Insurance cover.
- Poor written and/or oral comprehension of the French language
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU de Besançon
Besançon, 25000
CH Le Vinatier
Bron, 69678
Chs Epsan
Brumath, 67173
CHS de la Savoie
Chambéry, 73011
CH La Chartreuse
Dijon, 21000
CHU de DIJON
Dijon, 21079
CHS du Jura
Dole, 39108
CH Esquirol
Limoges, 87025
CH de Jury
Metz, 57073
CH de Novillars
Novillars, 25220
CH de Saint-Rémy et Nord Franche Comté
Saint-Rémy, 70160
CH de Semur en Auxois
Semur-en-Auxois, 21140
About this study
Official title: Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- Dental care education program, Surveillance
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental care education programOther
Dental care education program
SurveillanceOther
Surveillance
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Dental care education program |
| Surveillance | Placebo comparator | Not described Receives: Other: Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a Community Peridontal Index (CPI) ≥3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start20 Apr 2017
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512367
- Sponsor's protocol ID
- DENIS PHRC I 2014
- Acronym
- EBENE
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2015
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37444782Denis 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.
PubMed 27757142
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02512367
- Acronym / sponsor ID
- EBENE / DENIS PHRC I 2014
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dental care education program |
| Surveillance | Placebo comparator | Other: Surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental care education programDental care education program | Other | Intervention |
| SurveillanceSurveillance | Other | Surveillance |
Primary outcome
Proportion of patients with a Community Peridontal Index (CPI) ≥3
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 37444782Denis 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.
- Derived from this study: PubMed 27757142Denis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental care education program and Surveillance in people with Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a Community Peridontal Index (CPI) ≥3 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.