- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191200
Oral Status of Patients Suffering From SCHIZophrenia Followed at Charles Perrens Hospital (BUCCOSCHIZ)
Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- Centre Hospitalier Charles PERRENS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of the number of caries, fillings and teeth missing
Time Frame: 1 day
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The main outcome will be to measure the number of caries, fillings and teeth missing as stated in the DMFT Index.
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1 day
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Evaluation of oral hygiene
Time Frame: 1 day
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Oral hygiene will be measured with the simplified oral hygiene index (OHI-S)
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1 day
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Assessement of temporo mandibular dysfunction
Time Frame: 1 day
|
Number of patients suffering from temporo mandibular dysfunction (for patients who have replied yes to the 3Q/TMD screening).
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1 day
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Assessing of mouth dryness
Time Frame: 1 day
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Assessing mouth dryness through the Xerostomia Inventory survey.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Link between quality of life and oral health: survey
Time Frame: 1 day
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- Assessment of the link between quality of life and oral health through the GOHAI survey.
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1 day
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Social security coverage
Time Frame: 1 day
|
Number of patients and kind of social security coverage
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1 day
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Reason for primary appointment
Time Frame: 1 day
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Assessment for primary reason appointment and dental anxiety measured through the modified dental anxiety scale (MDAS).
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1 day
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Measurement of dental anxiety
Time Frame: 1 day
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Measurement of dental anxiety through the modified dental anxiety scale (MDAS).
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1 day
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French.
- 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
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUCCOSCHIZ2019
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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