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

Schizophrenia Clinical Trial

— QUALITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730832
• Other study ID #: DENIS 2015
• Status: Completed
• Phase: N/A
• Start date: June 20, 2016
• Est. completion date: April 19, 2017

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 19, 2017
• Est. primary completion date: April 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Questionnaires completed at D0

• Questionnaires completed at D15 (test-retest for 30 patients)

Locations

Country	Name	City	State
France	CH La Chartreuse	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of oral health by OHIP-14 scales		At inclusion
Primary	Evaluation of quality of life by GOHAI scales		At inclusion
Primary	Mc Nair Memory Questionnaire		At inclusion
Primary	Evaluation of negative symptoms by scale		At inclusion
Primary	Beck Depression Scale		At inclusion
Primary	Evaluation of quality of life by S-Qol		At inclusion