NCT00868049

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
Last Updated

March 24, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 23, 2009

Last Update Submit

March 23, 2009

Conditions

Obesity

Keywords

chewingdeglutitionorofacial motricityobesity

Study Arms (2)

1

Obese subjects

2

Normal-weight subjects

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School of University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (1)

  • 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. doi: 10.1016/j.ijporl.2005.06.005. Epub 2005 Jul 21.

    PMID: 16039726BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adriana B Figueiredo, MS

    Clinic Hospital of Medical School of University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

March 24, 2009

Record last verified: 2009-03

Locations

BR(1)