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Study of Stomatognathic System of the Obese Subjects (SSSCDFO)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00868049
First received: March 23, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.


Condition
Obesity

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 40
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Obese subjects
2
Normal-weight subjects

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.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868049

Locations
Brazil
Medical School of University of São Paulo
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Adriana B Figueiredo, MS Clinic Hospital of Medical School of University of São Paulo
  More Information

Publications:
Responsible Party: Adriana Bueno de Figueiredo/ Master Student, Clinic Hospital of Medical School of University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00868049     History of Changes
Other Study ID Numbers: ADRIANABF1
Study First Received: March 23, 2009
Last Updated: March 23, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
chewing
deglutition
orofacial motricity
obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014