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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: Questionnaires completed at D0; Other: Questionnaires completed at D15 (test-retest for 30 patients)

• Registration Number: NCT02730832
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-07
• Study Start: 2016-06-20
• Primary Completion: 2017-04-19
• Study Completion: 2017-04-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with schizophrenia	Questionnaires completed at D0	-
Patients with schizophrenia	Questionnaires completed at D15 (test-retest for 30 patients)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CH La Chartreuse; 🇫🇷 Dijon, France