- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868049
Study of Stomatognathic System of the Obese Subjects (SSSCDFO)
March 23, 2009 updated by: University of Sao Paulo
Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects
The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study was to identify differences in the stomatognathic system between obese and normal weight subjects.
The habitual chewing of a French bread and deglutition of solids and liquid was evaluated five times in obese subjects and controls.
The tonus of the lips, tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and palpation and defined as either normal or reduced.
Twenty obese patients (body mass index (BMI) > 30kg/m2) and twenty volunteers of normal weight (BMI 18.5-24.9
Kg/m2) were evaluated.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil, 05403-900
- Medical School of University of São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
twenty obese patients (6 Male /14 Female, mean age 32.2 ± 9.9, mean BMI 43,3 ± 9.6 Kg/m2) and twenty lean volunteer (4 Male / 16 Female mean age 30.7 ±6.7, mean BMI 22.3 ± 1.9 Kg/m2)
Description
Inclusion Criteria:
- healthy adults male and female
- healthy dentate
- body mass index (BMI) higher than 30 Kg/m2 for the obesity group and (BMI) lower than 25/m2 for the normal weight group.
Exclusion Criteria:
- face deformity
- alterations in morphology of lips and tongue
- without teeth or with lack of one tooth (excluding third molars)
- Malocclusion Angle's Class II and III
- pain during chewing
- pathology of the temporomandibular joint
- neurological pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
1
Obese subjects
|
2
Normal-weight subjects
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adriana B Figueiredo, MS, Clinic Hospital of Medical School of University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
March 23, 2009
First Submitted That Met QC Criteria
March 23, 2009
First Posted (Estimate)
March 24, 2009
Study Record Updates
Last Update Posted (Estimate)
March 24, 2009
Last Update Submitted That Met QC Criteria
March 23, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADRIANABF1
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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