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

      • São Paulo, Brazil, 05403-900
        • Medical School of University of São Paulo

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.

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

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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