Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000342011
Ethics application status
Approved
Date submitted
26/04/2010
Date registered
29/04/2010
Date last updated
29/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Head Posture and activity of masticatory and cervical muscles in subjects with and without temporomandibular disorders
Scientific title
Head Posture and activity of masticatory and cervical muscles in temporomandibular disorders
Secondary ID [1] 251665 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
temporomandibular disorder 257243 0
Condition category
Condition code
Musculoskeletal 257383 257383 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study evaluated the head posture of the subjects with and without temporomandibular disorder (TMD) by photogrammetry and electromyographic recordings of the masseter, anterior temporalis, upper trapezius and sternocleidomastoid (SCM) at rest and maximum intercuspal position were collected.The approximate duration of the assessments was two hours and the overall study was six months.
Intervention code [1] 256362 0
Not applicable
Comparator / control treatment
subjects with and without TMD were compared
Control group
Active

Outcomes
Primary outcome [1] 258294 0
To determine the head posture assessed by photogrametry
Timepoint [1] 258294 0
at time of participants' recruitment
Secondary outcome [1] 263995 0
to evaluate the electrical activity of masticatory and cervical muscles at mandibular rest and during maximal intercuspal position as assessed by electromyography
Timepoint [1] 263995 0
at time of participants' recruitment

Eligibility
Key inclusion criteria
As inclusion criteria for the study group (SG), it was considered temporomandibular disorder diagnosed by dental evaluation and /or presence of signals and symptoms of the dysfunction. For the control group (CG), it was considered absence of pain in the shoulder and cervical region, facial pain and/or headache, noises and limitation in the mandibular function.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of neuro-psychomotor disturbance, to be or have been submitted to physical therapy, speech therapy or orthodontics treatment (less than six months); pain complain in the inferior limbs; labyrinthic problems; squint; history of orthopedic trauma or malformation in the facial region, systemic or rheumatologic disease and use of analgesic, anti-inflammatory, muscular relaxants or antidepressant medicine.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2603 0
Brazil
State/province [1] 2603 0

Funding & Sponsors
Funding source category [1] 256867 0
Self funded/Unfunded
Name [1] 256867 0
Juliana Alves Souza
Country [1] 256867 0
Brazil
Primary sponsor type
Individual
Name
Juliana Alves Souza
Address
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country
Brazil
Secondary sponsor category [1] 256142 0
Individual
Name [1] 256142 0
Eliane Correa
Address [1] 256142 0
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country [1] 256142 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31095 0
Address 31095 0
Country 31095 0
Phone 31095 0
Fax 31095 0
Email 31095 0
Contact person for public queries
Name 14342 0
Juliana Alves Souza
Address 14342 0
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country 14342 0
Brazil
Phone 14342 0
55-55-32208234
Fax 14342 0
Email 14342 0
[email protected]
Contact person for scientific queries
Name 5270 0
Julina Alves Souza
Address 5270 0
Federal University of Santa Maria, Department of Physical Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country 5270 0
Brazil
Phone 5270 0
55-55-32208234
Fax 5270 0
Email 5270 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.