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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04191200
Other study ID # BUCCOSCHIZ2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 24, 2019
Est. completion date December 31, 2019

Study information

Verified date December 2019
Source Centre Hospitalier Charles Perrens, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to describe the oral health status of patients suffering from schizophrenia and schizoaffective disorders in a psychiatric institute in France.


Description:

Schizophrenia concerns 21 million people in the world and 600 000 in France according to the World Health Organization. This pathology decreases the patient's quality of life and one patient out of two will try to commit suicide and 10% will die. Oral health is an important factor for general well being. The litterature shows that schizophrenic patients tend to visit less dental surgeries than the general population. Patients will often visit the surgery in emergency and dentist often choses to extract instead of a restorative solution. Thus, schizophrenic subjects are 3,4 more likely to become edentulous compared to the general population.

This is a cross-sectional epidemiological study on patients suffering from schizophrenia and and schizoaffective disorders in a psychiatric institution. A dental assessment will be conducted to provide clinical data on oral health. (DMFT, hygiene, mouth dryness, prosthesis) and a survey of their diet, medication, oral quality of life, social security coverage and patients view regarding dental care (Anxiety and Healthcare renunciation).

This is an observational study (oral examination and survey), so no treatment will be compared. The oral health status will be evaluated during one single oral examination and survey during the patient's stay at hospital.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Schizophrenic patients and patients with schizoaffective disorders at the Charles Perrens Hospital

- Willing to participate in the study

- 18 years old and above

Exclusion Criteria:

- Patients mentally unable to participate or refusing to participate in this study.

- Patient hospitalized under duress

- Minor

- Patients unable to read, speak or write French

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier CHARLES PERRENS Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (4)

Bertaud-Gounot V, Kovess-Masfety V, Perrus C, Trohel G, Richard F. Oral health status and treatment needs among psychiatric inpatients in Rennes, France: a cross-sectional study. BMC Psychiatry. 2013 Sep 21;13:227. doi: 10.1186/1471-244X-13-227. — View Citation

Catteau C, Blaizot A, Duhamel A, Delzenne A, Devillers A, Frimat P. [Dental status and related factors in an occupational health service in Northern France]. Sante Publique. 2013 Nov-Dec;25(6):747-55. French. — View Citation

Curien R. & al; Evaluation de l'influence des psychotropes sur la santé bucco-dentaire chez une population de patients hospitalisés en secteur psychiatrique. Information Dentaire. 88 : (2006): 439-441

Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of the number of caries, fillings and teeth missing The main outcome will be to measure the number of caries, fillings and teeth missing as stated in the DMFT Index. 1 day
Primary Evaluation of oral hygiene Oral hygiene will be measured with the simplified oral hygiene index (OHI-S) 1 day
Primary Assessement of temporo mandibular dysfunction Number of patients suffering from temporo mandibular dysfunction (for patients who have replied yes to the 3Q/TMD screening). 1 day
Primary Assessing of mouth dryness Assessing mouth dryness through the Xerostomia Inventory survey. 1 day
Secondary Link between quality of life and oral health: survey - Assessment of the link between quality of life and oral health through the GOHAI survey. 1 day
Secondary Social security coverage Number of patients and kind of social security coverage 1 day
Secondary Reason for primary appointment Assessment for primary reason appointment and dental anxiety measured through the modified dental anxiety scale (MDAS). 1 day
Secondary Measurement of dental anxiety Measurement of dental anxiety through the modified dental anxiety scale (MDAS). 1 day
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