SchizophreniaSMI-DENTALNCT01315509
Dental Status of Patients With Severe Mental Illness
An observational study of Schizophrenia and Bipolar Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators aim to assess the dental status of psychiatric patients suffering from severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, PTSD
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Sep 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: THE SEVERE MENTAL ILL IN THE PSYCHIATRIC POPULATION OF THE HADASSAH MEDICAL ORGINIZATION -PSYCHIATRIC OUTPATIENT CLINIC
Who may be able to join
- All psychiatric patients suffering from schizophrenia, bipolar disorder, PTSD or resistant depression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to assess the dental status of psychiatric patients suffering from severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).
Read the detailed description
PATIENTS WILL BE ASSESSED USING THE
- DMFT (Decayed/Missing/Filled teeth)
AN EPIDEMILOGICAL ASSESSMENT TOOL THAT ASSESSES:
- THE NUMBER OF TEETH WITH CURRENT DECAY
- THE NUMBER OF TEETH MISSING
- THE NUMBER OF TEATH TREATED IN THE PAST (FILLED)
- CPI - Community Periodontal Index AN ASSESSMENT OF THE GUMS
- OHIP-Oral Health Impact Profile A SELF-RATING FORM TO ASSESS THE SOCIAL AND FUNCTIONAL AFECTS OF THIER DENTAL STATUS
- Conditions
- Schizophrenia, Bipolar Disorder, PTSD, Depression
- Keywords
- Severe mental illness, Dental measures, Resistant depression
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Stress Disorders, Post-Traumatic, Depression, Mental Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315509
- Sponsor's protocol ID
- SMIDENTIST-HMO-CTIL
- Acronym
- SMI-DENTAL
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
Publications
Matevosyan NR. Oral health of adults with serious mental illnesses: a review. Community Ment Health J. 2010 Dec;46(6):553-62. doi: 10.1007/s10597-009-9280-x. Epub 2009 Dec 29.
PubMed 20039129
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Status of Patients With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT01315509
- Acronym / sponsor ID
- SMI-DENTAL / SMIDENTIST-HMO-CTIL
- Conditions
- Schizophrenia, Bipolar Disorder, PTSD, Depression
- Keywords
- Severe mental illness, Dental measures, Resistant depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- 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 investigators aim to assess the dental status of psychiatric patients suffering from severe mental illness (schizophrenia, bipolar disorder, ptsd, resistant depression).
Detailed description
PATIENTS WILL BE ASSESSED USING THE
- DMFT (Decayed/Missing/Filled teeth)
AN EPIDEMILOGICAL ASSESSMENT TOOL THAT ASSESSES:
- THE NUMBER OF TEETH WITH CURRENT DECAY
- THE NUMBER OF TEETH MISSING
- THE NUMBER OF TEATH TREATED IN THE PAST (FILLED)
- CPI - Community Periodontal Index AN ASSESSMENT OF THE GUMS
- OHIP-Oral Health Impact Profile A SELF-RATING FORM TO ASSESS THE SOCIAL AND FUNCTIONAL AFECTS OF THIER DENTAL STATUS
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- THE SEVERE MENTAL ILL IN THE PSYCHIATRIC POPULATION OF THE HADASSAH MEDICAL ORGINIZATION -PSYCHIATRIC OUTPATIENT CLINIC
Key inclusion criteria (1 listed)
- All psychiatric patients suffering from schizophrenia, bipolar disorder, PTSD or resistant depression
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 22 Mar 2013.
- Background: PubMed 20039129Matevosyan NR. Oral health of adults with serious mental illnesses: a review. Community Ment Health J. 2010 Dec;46(6):553-62. doi: 10.1007/s10597-009-9280-x. Epub 2009 Dec 29.
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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 Schizophrenia and Bipolar Disorder, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 0 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 22 Mar 2013. 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 Israel. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315509, which also lists 1 linked publication.
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 22 Mar 2013.