NCT07304557

Brief Summary

The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. The main questions it aims to answer are: Does orofacial exercises improve function of temporomandibular disorders ? Does orofacial exercises decrease pain in temporomandibular disorders? Researchers will compare orofacial exercises and manual therapy to manual therapy. Participants will: Take manual therapy and orofacial exercises or manual therapy two days in every week for 6 weeks Assessment once every 2 weeks for tests

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress63%
Jun 2025Nov 2026

Study Start

First participant enrolled

June 19, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

Orofacial PainTMDTongue StrengthOMES

Outcome Measures

Primary Outcomes (1)

  • orofacial myofunctional evaluation with scores

    The Orofacial Myofunctional Evaluation with Scores (OMES) protocol is designed to assess oral dysfunctions through multiple subdomains. These subdomains include appearance and posture, mobility, function, swallowing, mastication, functional occlusion, and mandibular movement. Higher scores indicate better functional status. The protocol has not yet been validated in Turkish. It was first used in a pediatric population and has also demonstrated validity in individuals with temporomandibular disorders.

    From enrolment to the end of treatment at 6 weeks, in every two weeks

Secondary Outcomes (2)

  • Pain threshold level of temporomandibular joint and temporal regions

    From enrollment to the end of treatment at 6 weeks, once every two weeks.

  • Pain Level of Numerical Pain Scale

    From enrollment to the end of treatment at 6 weeks, once in every two weeks

Study Arms (2)

Orofacial Group

EXPERIMENTAL

The group planned to orofacial exercises and manual therapy intervention applying.

Other: ExerciseOther: Manual therapy

Control Group

ACTIVE COMPARATOR

the group planned to manual therapy apply.

Other: ExerciseOther: Manual therapy

Interventions

The orofacial and tongue exercises include four-directional tongue mobilizations and resisted tongue movements in forward and upward directions within the oral cavity to improve tongue mobility. In addition, safe mouth opening exercises, as well as cheek and lip exercises, are also included in the exercise program.

Also known as: Orofacial exercises, TMD exercises
Orofacial Group

Manual therapy will begin with cervical stretching, relaxation of the cervical paraspinal muscles, and release techniques for the sternocleidomastoid and scalene muscles. The intensity of these exercises will be adjusted according to the patient's and tissue's tolerance. Relaxation of the masticatory muscles will be achieved through massage applied externally to the jaw and the temporal region. Passive range-of-motion exercises will be performed to increase the mobility of the temporomandibular joint.

Control GroupOrofacial Group

Eligibility Criteria

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

You may qualify if:

  • aged people
  • Not having received physical therapy for the neck or jaw within the past three months.
  • No history of surgical or oncological treatment related to the neck or jaw.
  • Having a diagnosis of temporomandibular disorder according to the RDC/TMD criteria, specifically Group Ia, Group Ib, or Group IIa under Axis I.

You may not qualify if:

  • Individuals who are pregnant or suspected to be pregnant.
  • Individuals with rheumatologic diseases affecting the temporomandibular joint.
  • Individuals with a diagnosed psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, ALTINDAG, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Facial Pain

Interventions

ExerciseMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Science, Lecturer

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

June 19, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations