Temporomandibular DysfunctionNCT01331538
Temporomandibular Dysfunction and Cervical Posture
An observational study of Temporomandibular Dysfunction, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this research was to determine the existence of a correlation between the degree of temporomandibular dysfunction and cervical posture in different occlusal classes in adolescents. A cross-section, observational study was carried out, in which 296 adolescents took part. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Dysfunction
- How many people
- 296 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Mar 2010
- 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: adolescents aged between 10 and 20 years. As criteria for inclusion, age group and the presence of first permanent molar
Who may be able to join
- adolescents, aged between 10 and 20 years. As criteria for inclusion, age group and the presence of first permanent molar
Who cannot join
- Individuals undergoing orthodontic treatment, those with absent first molars and cases where it was impossible to clinically evaluate the occlusion were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Temporomandibular Dysfunction and Cervical Posture in Different Occlusal Angle Classes in Adolescents
The aim of this research was to determine the existence of a correlation between the degree of temporomandibular dysfunction and cervical posture in different occlusal classes in adolescents. A cross-section, observational study was carried out, in which 296 adolescents took part. For the evaluation, the patients were divided into groups according to the presence and severity of the temporomandibular dysfunction, using a questionnaire and occlusal Angle classification. The posture analysis was carried out using photogrammetry and the software Alcimage® to measure the predefined angle based on the protuberances of the Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum Vertex.
Read the detailed description
The evaluation of signs and symptoms of TMD was obtained from a Questionnaire (15) which includes information regarding difficulties opening the mouth and movement of the mandible, pains in the head, nape of the neck, neck or joint regions, noise in the temporomandibular joints, and the habit of clenching or grinding the teeth. The questionnaire is comprised of 10 questions with possible answers of yes (10 points), sometimes (5 points) and no (0 points). For each question, only one answer can be checked. The total score is used to classify the severity of the TMD as severe (70 to 100 points), moderate (45 to 65), mild (20 to 40) and no dysfunction (0 to 15).
The clinical (visual) assessment of head posture was conducted using a postural grid. Each subject was asked to remain in his or her normal posture, in a standing position. The self balance position was used to standardize the posture of each subject, asking them to look straight ahead, parallel to the floor, keeping the gaze horizontal
- Conditions
- Temporomandibular Dysfunction
- Keywords
- temporomandibular dysfunction, posture
- Medical subject headings
- Temporomandibular Joint Disorders
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 |
|---|---|---|
| adolescents with TMD | adolescents with temporomandibular dysfunction | |
| No TMD | adolescents without temporomandibular dysfunction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DysfunctionStudies of the same condition, open and under way.
- 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
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Investigators
- Lara Motta, Ms, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331538
- Sponsor's protocol ID
- 82622/08
- Status last verified
- Feb 2009
- First submitted
- 6 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Temporomandibular Dysfunction and Cervical Posture in Different Occlusal Angle Classes in Adolescents
- ClinicalTrials.gov ID
- NCT01331538
- Acronym / sponsor ID
- 82622/08
- Conditions
- Temporomandibular Dysfunction
- Keywords
- temporomandibular dysfunction, posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Apr 2011 (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 of this research was to determine the existence of a correlation between the degree of temporomandibular dysfunction and cervical posture in different occlusal classes in adolescents. A cross-section, observational study was carried out, in which 296 adolescents took part. For the evaluation, the patients were divided into groups according to the presence and severity of the temporomandibular dysfunction, using a questionnaire and occlusal Angle classification. The posture analysis was carried out using photogrammetry and the software Alcimage® to measure the predefined angle based on the protuberances of the Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum Vertex.
Detailed description
The evaluation of signs and symptoms of TMD was obtained from a Questionnaire (15) which includes information regarding difficulties opening the mouth and movement of the mandible, pains in the head, nape of the neck, neck or joint regions, noise in the temporomandibular joints, and the habit of clenching or grinding the teeth. The questionnaire is comprised of 10 questions with possible answers of yes (10 points), sometimes (5 points) and no (0 points). For each question, only one answer can be checked. The total score is used to classify the severity of the TMD as severe (70 to 100 points), moderate (45 to 65), mild (20 to 40) and no dysfunction (0 to 15).
The clinical (visual) assessment of head posture was conducted using a postural grid. Each subject was asked to remain in his or her normal posture, in a standing position. The self balance position was used to standardize the posture of each subject, asking them to look straight ahead, parallel to the floor, keeping the gaze horizontal
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescents with TMD | – | –adolescents with temporomandibular dysfunction |
| No TMD | – | –adolescents without temporomandibular dysfunction |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- adolescents aged between 10 and 20 years. As criteria for inclusion, age group and the presence of first permanent molar
Key inclusion criteria (1 listed)
- adolescents, aged between 10 and 20 years. As criteria for inclusion, age group and the presence of first permanent molar
Key exclusion criteria (1 listed)
- Individuals undergoing orthodontic treatment, those with absent first molars and cases where it was impossible to clinically evaluate the occlusion were excluded.
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 8 Apr 2011.
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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.
Lara Motta, Ms principal investigator
Nove de Julho University
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 Temporomandibular Dysfunction, run by University of Nove de Julho 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 1 inclusion and 1 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 8 Apr 2011. 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?
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 8 Apr 2011.