Dental DiseasesBUCCOSCHIZNCT04191200
Oral Status of Patients Suffering From SCHIZophrenia Followed at Charles Perrens Hospital
An observational study of Dental Diseases and Schizophrenia, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Diseases, Schizophrenia
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Schizophrenic adults and adults with schizoaffective disorders at the Charles Perrens Hospital.
Who may be able to join
- Schizophrenic patients and patients with schizoaffective disorders at the Charles Perrens Hospital
- Willing to participate in the study
- 18 years old and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens
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.
Read the 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.
- Conditions
- Dental Diseases, Schizophrenia
- Keywords
- Schizophrenia, Psychiatric institutions, Epidemiology, Schizophrenic disorder, Oral Health
- Medical subject headings
- Stomatognathic Diseases, Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Evaluation of oral hygiene
Oral hygiene will be measured with the simplified oral hygiene index (OHI-S)
Measured: 1 day
Assessement of temporo mandibular dysfunction
Number of patients suffering from temporo mandibular dysfunction (for patients who have replied yes to the 3Q/TMD screening).
Measured: 1 day
Assessing of mouth dryness
Assessing mouth dryness through the Xerostomia Inventory survey.
Measured: 1 day
Secondary outcomes (4)
Link between quality of life and oral health: survey
- Assessment of the link between quality of life and oral health through the GOHAI survey.
Measured: 1 day
Social security coverage
Number of patients and kind of social security coverage
Measured: 1 day
Reason for primary appointment
Assessment for primary reason appointment and dental anxiety measured through the modified dental anxiety scale (MDAS).
Measured: 1 day
Measurement of dental anxiety
Measurement of dental anxiety through the modified dental anxiety scale (MDAS).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start24 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191200
- Sponsor's protocol ID
- BUCCOSCHIZ2019
- Acronym
- BUCCOSCHIZ
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French.
PubMed 24620549Curien 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.
PubMed 24053587Catteau 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.
PubMed 24451420
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etat BUCCO-dentaire de Patients Atteints de SCHIZophrénie et de Troubles Schizo-affectif Suivis au Centre Hospitalier de Charles Perrens
- ClinicalTrials.gov ID
- NCT04191200
- Acronym / sponsor ID
- BUCCOSCHIZ / BUCCOSCHIZ2019
- Conditions
- Dental Diseases, Schizophrenia
- Keywords
- Schizophrenia, Psychiatric institutions, Epidemiology, Schizophrenic disorder, Oral Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenic adults and adults with schizoaffective disorders at the Charles Perrens Hospital.
Key inclusion criteria (3 listed)
- Schizophrenic patients and patients with schizoaffective disorders at the Charles Perrens Hospital
- Willing to participate in the study
- 18 years old and above
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of the number of caries, fillings and teeth missing
Time frame: 1 day
The main outcome will be to measure the number of caries, fillings and teeth missing as stated in the DMFT Index.
Evaluation of oral hygiene
Time frame: 1 day
Oral hygiene will be measured with the simplified oral hygiene index (OHI-S)
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).
Assessing of mouth dryness
Time frame: 1 day
Assessing mouth dryness through the Xerostomia Inventory survey.
4 secondary outcomes
Link between quality of life and oral health: survey
Time frame: 1 day
Social security coverage
Time frame: 1 day
Reason for primary appointment
Time frame: 1 day
Measurement of dental anxiety
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Background: PubMed 24620549Denis F. [The oral health of patients in psychiatric institutions and related comorbidities]. Soins Psychiatr. 2014 Jan-Feb;(290):40-4. French.
- BackgroundCurien 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
- Background: PubMed 24053587Bertaud-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.
- Background: PubMed 24451420Catteau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Diseases and Schizophrenia, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the number of caries, fillings and teeth missing (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191200, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.