SchizophreniaQUALITYNCT02730832
Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
A study testing Questionnaires completed at D0 and Questionnaires completed at D15 (test-retest for 30 patients) in people with Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Questionnaires completed at D0 and Questionnaires completed at D15 (test-retest for 30 patients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2016to 19 Apr 2017
- 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 diagnosis of schizophrenia according to DSM V
- Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years
- Patients older than 18 years
- Patients who have provided oral informed consent to take part in the study
Who cannot join
- Patients who are psychiatrically unstable or delusional
- Subjects on chemotherapy
- Adults under guardianship
- Patients without national health insurance cover
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.
The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.
To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.
- Conditions
- Schizophrenia
- Being tested
- Questionnaires completed at D0, Questionnaires completed at D15 (test-retest for 30 patients)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires completed at D0Other
Questionnaires completed at D15 (test-retest for 30 patients)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Experimental | Not described Receives: Other: Questionnaires completed at D0; Other: Questionnaires completed at D15 (test-retest for 30 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of oral health by OHIP-14 scales
Measured: At inclusion
Evaluation of quality of life by GOHAI scales
Measured: At inclusion
Mc Nair Memory Questionnaire
Measured: At inclusion
Evaluation of negative symptoms by scale
Measured: At inclusion
Beck Depression Scale
Measured: At inclusion
Evaluation of quality of life by S-Qol
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start20 Jun 2016
- Primary completion19 Apr 2017
- Study completion19 Apr 2017
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT02730832
- Sponsor's protocol ID
- DENIS 2015
- Acronym
- QUALITY
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Siu-Paredes F, Rude N, Rat C, Reynaud M, Hamad M, Moussa-Badran S, Denis F. The Schizophrenia Coping Oral Health Profile. Development and Feasibility. Transl Neurosci. 2018 Jun 20;9:78-87. doi: 10.1515/tnsci-2018-0014. eCollection 2018.
PubMed 29967693Frederic D, Corinne R, Matthieu R, Francesca SP, Stephanie TJ, Nathalie R. The Schizophrenia Oral Health Profile: Development and Feasibility. Transl Neurosci. 2018 Sep 22;9:123-131. doi: 10.1515/tnsci-2018-0019. eCollection 2018.
PubMed 30263228
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02730832
- Acronym / sponsor ID
- QUALITY / DENIS 2015
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 19 Apr 2017 (actual)
- First posted
- 7 Apr 2016 (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.
Apart from objective criteria for the evaluation of oral health (CAO, CPI…), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.
The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.
To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | Other: Questionnaires completed at D0, Other: Questionnaires completed at D15 (test-retest for 30 patients) |
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 diagnosis of schizophrenia according to DSM V
- Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years
- Patients older than 18 years
- Patients who have provided oral informed consent to take part in the study
Key exclusion criteria (4 listed)
- Patients who are psychiatrically unstable or delusional
- Subjects on chemotherapy
- Adults under guardianship
- Patients without national health insurance cover
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 |
|---|---|---|
| Questionnaires completed at D0 | Other | Patients with schizophrenia |
| Questionnaires completed at D15 (test-retest for 30 patients) | Other | Patients with schizophrenia |
Primary outcome
Perception of oral health by OHIP-14 scales
Time frame: At inclusion
Evaluation of quality of life by GOHAI scales
Time frame: At inclusion
Mc Nair Memory Questionnaire
Time frame: At inclusion
Evaluation of negative symptoms by scale
Time frame: At inclusion
Beck Depression Scale
Time frame: At inclusion
Evaluation of quality of life by S-Qol
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 29967693Siu-Paredes F, Rude N, Rat C, Reynaud M, Hamad M, Moussa-Badran S, Denis F. The Schizophrenia Coping Oral Health Profile. Development and Feasibility. Transl Neurosci. 2018 Jun 20;9:78-87. doi: 10.1515/tnsci-2018-0014. eCollection 2018.
- Derived from this study: PubMed 30263228Frederic D, Corinne R, Matthieu R, Francesca SP, Stephanie TJ, Nathalie R. The Schizophrenia Oral Health Profile: Development and Feasibility. Transl Neurosci. 2018 Sep 22;9:123-131. doi: 10.1515/tnsci-2018-0019. eCollection 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires completed at D0 and Questionnaires completed at D15 (test-retest for 30 patients) in people with Schizophrenia, run by Centre Hospitalier Universitaire Dijon at 1 site 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 4 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: finished, as of the sponsor's last update on 6 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 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perception of oral health by OHIP-14 scales (time frame: At inclusion). The study lists 6 primary outcomes in all. 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 NCT02730832, 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 6 Feb 2026.