Temporomandibular DisorderNCT05704998
INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER
A study testing Physiotherapy in people with Temporomandibular Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship between neck posture and balance in patients with posterior edentulous and full-toothed temporomandibular disorder and to compare the effectiveness of the physiotherapy program to be applied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Aug 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the relationship between neck posture and balance in patients with posterior edentulous and full-toothed temporomandibular disorder and to compare the effectiveness of the physiotherapy program to be applied.
Read the 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.
- Conditions
- Temporomandibular Disorder
- Being tested
- Physiotherapy
- Keywords
- temporomandibular joint, physiotherapy, posture exercises, posterior tooth loss
- 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.
PhysiotherapyOther
Also called Manuel therapy, Kinesio taping
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
| Study group | Role | What they receive |
|---|---|---|
| Posterior Edentulous Group | Experimental | Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks. Receives: Other: Physiotherapy |
| Fully Toothed Group | Experimental | Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular Range of Motion
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)
Measured: Baseline and week 6
Posture
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)
Measured: Baseline and week 6
Balance
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)
Measured: Baseline and week 6
Secondary outcomes (3)
Pain Score with Numeric Pain Rating Scale (NPRS)
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)
Measured: Baseline and week 6
Active Cervical Range of Motion
Measured by a phone app named Clinometer. Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score)
Measured: Baseline and week 6
Beck Depression Inventory
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)
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Jun 2022
- Primary completion15 Jul 2022
- Study completion30 Aug 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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), received same treatment.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rübeysa Türedi, Dokuz Eylul University
- Investigators
- Selnur NARİN ARAL, Assoc. Dr., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704998
- Sponsor's protocol ID
- DEU.HSI.MSc-2019970200
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER
- ClinicalTrials.gov ID
- NCT05704998
- Acronym / sponsor ID
- DEU.HSI.MSc-2019970200
- Conditions
- Temporomandibular Disorder
- Keywords
- temporomandibular joint, physiotherapy, posture exercises, posterior tooth loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- 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 is to investigate the relationship between neck posture and balance in patients with posterior edentulous and full-toothed temporomandibular disorder and to compare the effectiveness of the physiotherapy program to be applied.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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), received same treatment.
| Arm | Type | Receives |
|---|---|---|
| Posterior Edentulous Group | Experimental | Other: PhysiotherapyPosture exercises, manual therapy and kinesio taping were applied twice a week for six weeks. |
| Fully Toothed Group | Experimental | Other: PhysiotherapyPosture exercises, manual therapy and kinesio taping were applied twice a week for six weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Being positive for COVID-19
- Sports injuries
- Presence of trauma
- Whiplash
- Degenerative changes
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 |
|---|---|---|
| PhysiotherapyAlso: Manuel therapy, Kinesio tapingPosture 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 | Fully Toothed Group, Posterior Edentulous Group |
Primary outcome
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)
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)
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)
3 secondary outcomes
Pain Score with Numeric Pain Rating Scale (NPRS)
Time frame: Baseline and week 6
Active Cervical Range of Motion
Time frame: Baseline and week 6
Beck Depression Inventory
Time frame: Baseline and week 6
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 30 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Selnur NARİN ARAL, Assoc. Dr. principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Temporomandibular Disorder, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 13 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 30 Jan 2023. 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 Turkey (Türkiye). 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?
Mandibular Range of Motion (time frame: Baseline and week 6). The study lists 3 primary outcomes in all. 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 30 Jan 2023.