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INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring temporomandibular joint, physiotherapy, posture exercises, posterior tooth loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Posterior Edentulous Group

Fully Toothed Group

Arm Description

Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.

Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
January 21, 2023
Last Updated
January 21, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05704998
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
temporomandibular joint, physiotherapy, posture exercises, posterior tooth loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior Edentulous Group
Arm Type
Experimental
Arm Description
Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.
Arm Title
Fully Toothed Group
Arm Type
Experimental
Arm Description
Posture exercises, manual therapy and kinesio taping were applied twice a week for six weeks.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Manuel therapy, Kinesio taping
Intervention Description
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
Primary Outcome Measure Information:
Title
Mandibular Range of Motion
Description
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)
Time Frame
Baseline and week 6
Title
Posture
Description
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)
Time Frame
Baseline and week 6
Title
Balance
Description
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)
Time Frame
Baseline and week 6
Secondary Outcome Measure Information:
Title
Pain Score with Numeric Pain Rating Scale (NPRS)
Description
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)
Time Frame
Baseline and week 6
Title
Active Cervical Range of Motion
Description
Measured by a phone app named Clinometer. Change = ( Week 6 Score - Baseline Score) Comparison = (Posterior Edentulous Group Change Score - Fully Toothed Group Change Score)
Time Frame
Baseline and week 6
Title
Beck Depression Inventory
Description
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)
Time Frame
Baseline and week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selnur NARİN ARAL, Assoc. Dr.
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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INVESTIGATION AND COMPARISON OF THE EFFECTS OF POSTURE EXERCISES ON DYSFUNCTION, POSTURE AND BALANCE IN INDIVIDUALS WITH POSTERIOR EDENTULOUS AND FULL-TOOTHED TEMPOROMANDIBULAR DISORDER

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