Study of Stomatognathic System of the Obese Subjects (SSSCDFO)
| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2009 | ||||
| Last Updated Date | March 23, 2009 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Stomatognathic System of the Obese Subjects | ||||
| Official Title ICMJE | Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects | ||||
| Brief Summary | The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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) |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Valera FC, Trawitzki LV, Anselmo-Lima WT. Myofunctional evaluation after surgery for tonsils hypertrophy and its correlation to breathing pattern: a 2-year-follow up. Int J Pediatr Otorhinolaryngol. 2006 Feb;70(2):221-5. Epub 2005 Jul 21. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 58 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00868049 | ||||
| Other Study ID Numbers ICMJE | ADRIANABF1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Adriana Bueno de Figueiredo/ Master Student, Clinic Hospital of Medical School of University of Sao Paulo | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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