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Laser Therapy on TMJ Disorders After Head and Neck Cancer.

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Temporomandibular Joint Disorders

Treatments

Other: traditional physical therapy exercise program
Device: High intensity laser
Device: placebo High intensity laser

Study type

Interventional

Funder types

Other

Identifiers

NCT05868460
P.T.REC/012/004499

Details and patient eligibility

About

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 aetiology of TMD is multifactorial and complex.

Full description

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, either as 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 tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.

High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.

Enrollment

60 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.
  2. Patients with 20 to 60 years old.
  3. 6 months after ending radiotherapy.

Exclusion criteria

  1. Patients with implants.
  2. Current metastasis.
  3. Continuing radiotherapy.
  4. Pregnant females.
  5. Sensitivity to phototherapy.
  6. Bells palsy.
  7. Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
  8. Subjects who received analgesics or antidepressants.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Group A (High Intensity Laser Therapy Group)
Experimental group
Description:
patients will receive HILT in addition to traditional physical therapy exercise program
Treatment:
Device: High intensity laser
Other: traditional physical therapy exercise program
Group B (Placebo-Control Group)
Placebo Comparator group
Description:
patients will receive placebo HILT in addition to traditional physical therapy exercise program
Treatment:
Device: placebo High intensity laser
Other: traditional physical therapy exercise program

Trial contacts and locations

1

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Central trial contact

Nesma M Allam, PhD

Data sourced from clinicaltrials.gov

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