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

NCT02730832 | Completed

• 1 other identifier: DENIS 2015
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (6)

• Perception of oral health by OHIP-14 scales

  At inclusion

• Evaluation of quality of life by GOHAI scales

  At inclusion

• Mc Nair Memory Questionnaire

  At inclusion

• Evaluation of negative symptoms by scale

  At inclusion

• Beck Depression Scale

  At inclusion

• Evaluation of quality of life by S-Qol

  At inclusion

Study Arms (1)

Patients with schizophrenia

EXPERIMENTAL

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

Interventions

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

Patients with schizophrenia

Questionnaires completed at D0 OTHER

Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CH La Chartreuse

Dijon, 21033, France

Location

Related Publications (2)

• 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.

  PMID: 29967693 RESULT

• Frederic 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.

  PMID: 30263228 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 7, 2016
• Study Start: June 20, 2016
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)