ObesitySSSCDFONCT00868049
Study of Stomatognathic System of the Obese Subjects
An observational study of Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medical School of University of São Paulo
São Paulo, São Paulo, 05403-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Keywords
- chewing, deglutition, orofacial motricity, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Obese subjects | |
| 2 | Normal-weight subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Adriana B Figueiredo, MS, Principal investigator, Clinic Hospital of Medical School of University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868049
- Sponsor's protocol ID
- ADRIANABF1
- Acronym
- SSSCDFO
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.ijporl.2005.06.005. Epub 2005 Jul 21.
PubMed 16039726
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Stomatognathic System,Chewing and Deglutition Functions in the Obese Subjects
- ClinicalTrials.gov ID
- NCT00868049
- Acronym / sponsor ID
- SSSCDFO / ADRIANABF1
- Conditions
- Obesity
- Keywords
- chewing, deglutition, orofacial motricity, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Obese subjects |
| 2 | – | –Normal-weight subjects |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
- Background: PubMed 16039726Valera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana B Figueiredo, MS principal investigator
Clinic Hospital of Medical School of University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2009.