NCT05704998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 21, 2023

Last Update Submit

January 21, 2023

Conditions

Temporomandibular Disorder

Keywords

temporomandibular jointphysiotherapyposture exercisesposterior tooth loss

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    Baseline and week 6

Secondary Outcomes (3)

  • Pain Score with Numeric Pain Rating Scale (NPRS)

    Baseline and week 6

  • Active Cervical Range of Motion

    Baseline and week 6

  • Beck Depression Inventory

    Baseline and week 6

Study Arms (2)

Posterior Edentulous Group

EXPERIMENTAL

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

Other: Physiotherapy

Fully Toothed Group

EXPERIMENTAL

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

Other: Physiotherapy

Interventions

PhysiotherapyOTHER

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

Also known as: Manuel therapy, Kinesio taping
Fully Toothed GroupPosterior Edentulous Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Selnur NARİN ARAL, Assoc. Dr.

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 21, 2023

First Posted

January 30, 2023

Study Start

June 1, 2022

Primary Completion

July 15, 2022

Study Completion

August 30, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations

TU(1)