Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia (QUALITY)

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21033
        • CH La Chartreuse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are psychiatrically unstable or delusional
  • Subjects on chemotherapy
  • Adults under guardianship
  • Patients without national health insurance cover

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with schizophrenia
Other: Questionnaires completed at D0
Other: Questionnaires completed at D15 (test-retest for 30 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perception of oral health by OHIP-14 scales
Time Frame: At inclusion
At inclusion
Evaluation of quality of life by GOHAI scales
Time Frame: At inclusion
At inclusion
Mc Nair Memory Questionnaire
Time Frame: At inclusion
At inclusion
Evaluation of negative symptoms by scale
Time Frame: At inclusion
At inclusion
Beck Depression Scale
Time Frame: At inclusion
At inclusion
Evaluation of quality of life by S-Qol
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2016

Primary Completion (Actual)

April 19, 2017

Study Completion (Actual)

April 19, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimated)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENIS 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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