Temporomandibular DisorderNCT00743223
The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder
An observational study of Temporomandibular Disorder, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial summary
The aim of this study was to verify the frequency of the forward head posture in subjects with temporomandibular disorder and to compare them with control group Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- The measure of the cervical posture
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Dec 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was randomized with one hundred subjects that were divided fifty for study group and fifty of the control group with age between 18 and 65 years old, of both sexes. The volunteers were selected among the individuals who went to the clinic of orofacial pain and TMD of São Paulo Hospital and the dental offices of the researchers
Who may be able to join
- Study group
- The criteria of inclusion of the individuals for this group were:
- Individuals whose main complaint were pain in the muscles of the chew or the TMJ
- To present pain of the muscle or to articulate during the functional tests
- Maximum opening interincisal equal or minor than 40 mm
- Crontrol group
Show all 10Show fewer
- The criteria of inclusion of the individuals for this group were:
- Individuals who underwent routine dental treatment
- Individuals without TMD complaint
- Maximum opening interincisal bigger than 40 mm
Who cannot join
- There are not
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to verify the frequency of the forward head posture in subjects with temporomandibular disorder and to compare them with control group
Read the detailed description
Postural habit is defined as "the attitude of the body" being characterized as good when the parts of the body muscles and bones are lined up and work together in a harmonious form protecting the body of injury or gradual deformity and independently the attitude. The bad posture is a bad habit, but it can be which results in the disagreement of some parts of the body. These are at risk of injury or pain due to and increased tension that the disagreement imposes to the support structures. Several study confirm this occurrence relating that this the attitude can alter itself principally if a discomfort occurs. When it occurs there will be the installation of alterations, limitation of movements or even deformity, leading it to the development of an abnormal of posture of the body which will be able to reduce the functional capacity of various structures and organs of the human body.
The forward head posture is a common abnormality in cervical spine that can contribute to perpetuation the trigger points in muscles of the head as well as some kinds of temporomandibular disorder. It was suggested its influence in the treatment of patients with orofacial pain and TMD the FHP may occur a result of an acute trauma or if develop itself gradually because of an inadequate position.
- Conditions
- Temporomandibular Disorder
- Being tested
- The measure of the cervical posture
- Keywords
- temporomandibular disorder, orofacial pain, posture of the head
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The measure of the cervical postureOther
Also called there are not brand or serial numbers.
The investigation of the cervical position consisted of locating the individual in side view with the parallel feet in erect position and tracing an imprisoned plumb wire to the ceiling and tangent to the kyphosis curve of the thoracic column. With a ruler it was verified at a distance of this line until the point deepest of the cervical lordosis curve.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Study-group: The volunteers were selected on a randomized form among the individuals who went to the clinic of orofacial pain and temporomandibular disorders of São Paulo Hospital. Receives: Other: The measure of the cervical posture | |
| 2 | Control-group: The volunteers were selected on a randomized form among the individuals who went to the dental offices of the researchers. Receives: Other: The measure of the cervical posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: frequency of the forward head posture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startOct 2006
- Study completionDec 2007
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Investigators
- GUSTAVO VINHOLI, DENTIST, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743223
- Sponsor's protocol ID
- CEP-UNIFESP1175/06
- Status last verified
- Aug 2008
- First submitted
- 26 Aug 2008
- Last updated
- 28 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT00743223
- Acronym / sponsor ID
- CEP-UNIFESP1175/06
- Conditions
- Temporomandibular Disorder
- Keywords
- temporomandibular disorder, orofacial pain, posture of the head
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Aug 2008 (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 study was to verify the frequency of the forward head posture in subjects with temporomandibular disorder and to compare them with control group
Detailed description
Postural habit is defined as "the attitude of the body" being characterized as good when the parts of the body muscles and bones are lined up and work together in a harmonious form protecting the body of injury or gradual deformity and independently the attitude. The bad posture is a bad habit, but it can be which results in the disagreement of some parts of the body. These are at risk of injury or pain due to and increased tension that the disagreement imposes to the support structures. Several study confirm this occurrence relating that this the attitude can alter itself principally if a discomfort occurs. When it occurs there will be the installation of alterations, limitation of movements or even deformity, leading it to the development of an abnormal of posture of the body which will be able to reduce the functional capacity of various structures and organs of the human body.
The forward head posture is a common abnormality in cervical spine that can contribute to perpetuation the trigger points in muscles of the head as well as some kinds of temporomandibular disorder. It was suggested its influence in the treatment of patients with orofacial pain and TMD the FHP may occur a result of an acute trauma or if develop itself gradually because of an inadequate position.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: The measure of the cervical postureStudy-group: The volunteers were selected on a randomized form among the individuals who went to the clinic of orofacial pain and temporomandibular disorders of São Paulo Hospital. |
| 2 | – | Other: The measure of the cervical postureControl-group: The volunteers were selected on a randomized form among the individuals who went to the dental offices of the researchers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was randomized with one hundred subjects that were divided fifty for study group and fifty of the control group with age between 18 and 65 years old, of both sexes. The volunteers were selected among the individuals who went to the clinic of orofacial pain and TMD of São Paulo Hospital and the dental offices of the researchers
Key inclusion criteria (10 listed)
- Study group
- Individuals whose main complaint were pain in the muscles of the chew or the TMJ
- To present pain of the muscle or to articulate during the functional tests
- Maximum opening interincisal equal or minor than 40 mm
- Crontrol group
Key exclusion criteria (1 listed)
- There are not
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The measure of the cervical postureAlso: there are not brand or serial numbers.The investigation of the cervical position consisted of locating the individual in side view with the parallel feet in erect position and tracing an imprisoned plumb wire to the ceiling and tangent to the kyphosis curve of the thoracic column. With a ruler it was verified at a distance of this line until the point deepest of the cervical lordosis curve. | Other | 1, 2 |
Primary outcome
Outcome Measure: frequency of the forward head posture
Time frame: one year
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 28 Aug 2008.
- Barros TP, Campolongo GD, Novaes AP, Amantéa DV. The importance of the postural evaluation in patients with temporomandibular joint dysfunction. Acta ortop. Bras, 2004;12(3),jul/set:155-59Link provided by the sponsor.
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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.
GUSTAVO VINHOLI, DENTIST principal investigator
Federal 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 Temporomandibular Disorder, run by Federal University of Mato Grosso 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 10 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 28 Aug 2008. 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.
What does the primary outcome measure?
Outcome Measure: frequency of the forward head posture (time frame: one year). It is what the study was designed to measure, not a finding.
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 28 Aug 2008.