Temporomandibular DisorderNCT01331031
Parafunctional Habits and Temporomandibular Disorder in Adolescents
An observational study of Temporomandibular Disorder and Adolescent Behavior, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in public school . Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Adolescent Behavior
- How many people
- 244 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Jan 2011
- 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: 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system.
Who may be able to join
- age: 10 to 20 years old
Who cannot join
- no signing a term of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Parafunctional Habits and Signs and Symptoms Temporomandibular Disorder in Adolescents
The disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in public school . The investigators used the questionnaire for selection of orofacial pain and temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the presence or absence of signs and symptoms of TMD.
Read the detailed description
For the assessment of signs and symptoms of TMD and parafunctional habits, 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system were analyzed. The participants were submitted to the self-explanatory questionnaire for screening recommended by the American Academy of Orofacial Pain for the determination of orofacial pain and TMD. This questionnaire is made up of ten guided questions with yes or no responses to the most frequent signs and symptoms of orofacial pain and TMD. According to the Academy, three or more affirmative responses are an indication of TMD. Patient history and a detailed clinical exam were performed for the assessment of the presence or absence of parafunctional habits.
The frequency of signs and symptoms was analyzed and the data were described based on gender and age. The SPSS 12.0 program was used for the statistical analysis and the data were treated using the chi-square test.
- Conditions
- Temporomandibular Disorder, Adolescent Behavior
- Keywords
- temporomandibular disorder, adolescents
- Medical subject headings
- Temporomandibular Joint Disorders, Adolescent Behavior
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 | Adolescents between 10 and 20 years of age and enrolled in a municipal school system. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Investigators
- Lara Motta, Ms, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331031
- Sponsor's protocol ID
- 013/2008
- Status last verified
- Oct 2010
- First submitted
- 6 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Parafunctional Habits and Signs and Symptoms Temporomandibular Disorder in Adolescents
- ClinicalTrials.gov ID
- NCT01331031
- Acronym / sponsor ID
- 013/2008
- Conditions
- Temporomandibular Disorder, Adolescent Behavior
- Keywords
- temporomandibular disorder, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 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 disorders that affect the temporomandibular joint (TMJ) are responsible for the diverse symptoms. Objective: To evaluate whether or not the relationship between signs or symptoms of TMD and presence of harmful habits. The investigators evaluated 244 adolescents enrolled in public school . The investigators used the questionnaire for selection of orofacial pain and temporomandibular disorders, recommended by American Academy of Orofacial Pain to assess the presence or absence of signs and symptoms of TMD.
Detailed description
For the assessment of signs and symptoms of TMD and parafunctional habits, 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system were analyzed. The participants were submitted to the self-explanatory questionnaire for screening recommended by the American Academy of Orofacial Pain for the determination of orofacial pain and TMD. This questionnaire is made up of ten guided questions with yes or no responses to the most frequent signs and symptoms of orofacial pain and TMD. According to the Academy, three or more affirmative responses are an indication of TMD. Patient history and a detailed clinical exam were performed for the assessment of the presence or absence of parafunctional habits.
The frequency of signs and symptoms was analyzed and the data were described based on gender and age. The SPSS 12.0 program was used for the statistical analysis and the data were treated using the chi-square test.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | –Adolescents between 10 and 20 years of age and enrolled in a municipal school system. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system.
Key inclusion criteria (1 listed)
- age: 10 to 20 years old
Key exclusion criteria (1 listed)
- no signing a term of informed consent
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 7 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
University of Nove de Julho
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 Disorder and Adolescent Behavior, 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 7 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 7 Apr 2011.