- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704998
INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was planned as a quasi-experimental controlled study. A total of 26 patients with temporomandibular disorder, aged between 18-70 years, 13 of whom were in the Posterior Edentulous Group (PDG) and 13 were in the Fully Toothed Group (TDG), were included. Posture exercises and manual therapy were applied to both groups twice a week for six weeks. Mandibular range of motion, pain, muscle strength, deep neck flexor endurance, flexibility, shortness, range of motion (ROM), pressure pain threshold (BAE), psychological state, posture and balance were evaluated before and after exercise.
The results of the study showed that six weeks of postural exercises and manual therapy provided significant improvement in all values (p<0.05). A significant difference was found in pain, muscle strength, ROM, BAE and balance in PDG compared to TDG (p<0.05).
The results of the study showed that symptoms can be improved by giving posture exercises in patients with tempromandibular disorder. It was concluded that the improvement in PDG was higher than in TDG.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey, 35330
- Dokuz Eylül University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being diagnosed with Myofascial Temporomandibular Disorder according to The Research Diagnostic Criteria for Temporomandibular Disorders
- Complaining of head or neck pain
- Having temporomandibular joint pain for at least 3 months
- Not having used an intraoral plaque before
- Able to follow the treatment protocol regularly
- Ability and willingness to communicate verbally
Exclusion Criteria:
- Being positive for COVID-19
- Sports injuries
- Presence of trauma
- Whiplash
- Degenerative changes
- Signs or symptoms of disc displacement, osteoarthrosis or osteoarthritis of temporomandibular joint
- Post-operative conditions involving the cervical or temporomandibular region
- Burn involving the cervical region and the temporomandibular region
- Patients using analgesics or muscle relaxants up to 8 hours before the physical therapy procedure
- Those with hypermobility in cervical movements
- Those who have received physiotherapy or other treatment from the head / neck area in the last 12 months
- Acute infections or any systemic disorder
- Osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Posterior Edentulous Group
Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.
|
Posture exercises, myofascial release techniques, sternocleidomastoideus and upper trapezius kinesio taping, trigger point ischemic compression, suboccipital release technique, cervical traction, deep neck flexors endurance exercises, massage
Other Names:
|
|
Experimental: Fully Toothed Group
Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.
|
Posture exercises, myofascial release techniques, sternocleidomastoideus and upper trapezius kinesio taping, trigger point ischemic compression, suboccipital release technique, cervical traction, deep neck flexors endurance exercises, massage
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mandibular Range of Motion
Time Frame: Baseline and week 6
|
Maximal mouth opening, protrusion and both lateral excursions was recorded in millimeters. Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score) |
Baseline and week 6
|
|
Posture
Time Frame: Baseline and week 6
|
Posture evaluated with New York Posture Rating Chart.
Possible scores range from 13 (bad posture) to 65 (very good posture) Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score)
|
Baseline and week 6
|
|
Balance
Time Frame: Baseline and week 6
|
Balance evaluated with TETRAX® Interactive Balance System. Possible scores range from 0 (minimum fall risk) to 100 (high fall risk). Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score) |
Baseline and week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Score with Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and week 6
|
NPRS is a validated, self-reported instrument assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score) |
Baseline and week 6
|
|
Active Cervical Range of Motion
Time Frame: Baseline and week 6
|
Measured by a phone app named Clinometer.
Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score)
|
Baseline and week 6
|
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Beck Depression Inventory
Time Frame: Baseline and week 6
|
Beck Depression Inventory, which is a validated, self-reported scale, consists of 21 questions. According to the total result, 0-9 points indicates minimal depression, 10-16 points mild depression, 17-29 moderate depression, 30-63 severe depression. Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score) |
Baseline and week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selnur NARİN ARAL, Assoc. Dr., Dokuz Eylül University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEU.HSI.MSc-2019970200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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