NCT07151469

Brief Summary

Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The etiology of TMD is multifactorial and complex. It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, as either a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumors may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable head-and-neck-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

August 25, 2025

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain pressure threshold

    The pain pressure threshold over the temporalis and masseter muscles will be assessed using an algometry with a 1 cm2 probe tip.lower thresholds indicating increased tenderness and sensitivity

    at baseline and at 8 weeks

  • Maximal interincisal opening

    The stainless steel vernier caliper, which has two arms-one fixed and one movable-connected by a calibrated scale, showed exceptional reliability for measuring mouth opening.Millimeters were used to measure the separation between the incisal edges of the upper and lower incisor teeth

    at baseline and at 8 weeks

Secondary Outcomes (2)

  • Functional disability

    at baseline and at 8 weeks

  • Quality of life (Oral health Impact Profile

    at baseline and at 8 weeks

Study Arms (3)

Kaltenborn mobilization

EXPERIMENTAL

A certified therapist administered TMJ KM in the following way. The therapist stood behind the seated patient, placing their palms on both sides of the patient's head, with the thumbs over the zygomatic arches, to stabilize the head.

Other: Kaltenborn mobilization

active release technique

EXPERIMENTAL

This deep tissue therapy technique is primarily used to break up adhesions and scar tissue on the surrounding muscle and ligaments. However, this technique has been proven to be a very effective method for treating TMD

Other: active release technique

control

NO INTERVENTION

No intervention

Interventions

The therapist applies gentle traction to the mandible, maintained for approximately 20 to 30 seconds, to create space in the joint. This is done by pulling the jaw downward and slightly forward, which can help alleviate pressure and pain. This hand placement allowed the therapist to apply transverse force across the mandible as necessary, while at the same time allowing an anterior-inferior gliding force to the mandible on the side of restriction, while also controlling the unrestricted side inhibiting any excessive mandibular forward gliding with the other hand. The mobilization is then initiated with Grade I, which involves small-amplitude movements performed at the beginning of the range of joint play to reduce pain and muscle guarding. This is followed by Grade II mobilization, which consists of larger amplitude movements within the mid-range of joint play to enhance joint mobility and decrease pain without reaching the joint's full resistance barrier

Kaltenborn mobilization

This deep tissue therapy technique is primarily used to break up adhesions and scar tissue on the surrounding muscle and ligaments. However, this technique has been proven to be a very effective method for treating TMD.While there are several muscles connected with the movement of the TMJ, it is thought that the major players are the digastricus, masseter, and lateral pterygoid muscles

active release technique

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • An experienced oral and maxillofacial surgeon will diagnose patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients.
  • Patients with 20 to 60 years old.
  • months after ending radiotherapy.

You may not qualify if:

  • Patients with implants.
  • Current metastasis.
  • Continuing radiotherapy.
  • Pregnant females.
  • Sensitivity to phototherapy.
  • Bell's palsy.
  • Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
  • Subjects who received analgesics or antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 3753450, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 3, 2025

Study Start

October 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 10, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations