Evaluation of the Effect of Laser Therapy on Lateral Pterygoid Muscle in Patients With Wilke's Stage I and II Temporomandibular Disorders (TMD): Case Series Study

June 10, 2025 updated by: Aliaa ibrahim fathy, Cairo University
The purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with Wilke's stage I and II temporomandibular disorders (TMD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  1. Patients age between 16-50 years with no sex predilection.
  2. Patients who will be free from any systemic diseases that affect temporomandibular joint.
  3. Patients who will be diagnosed with wilk's stage I and II temporomandibular disorders (TMD).
  4. Patients who will be ready to give informed consent.

Exclusion Criteria:

  1. Patients with previous temporo-mandibular surgeries.
  2. Patients with previous facial fracture.
  3. Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
  4. Patients who will not attend the proposed treatment sessions or follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one arm(case series0
Procedure: laser therapy in TMD

In this study patients will receive the Low-level laser therapy with a 635 nm wavelength diode laser (Lasotronix, Diode Laser DiodeLX model SMART M; Zytnia, Piaseczno, Poland) with 200 mW in a continuous mode, using a handpiece with a cylindrical applicator with a diameter of 8 mm in contact mode extra-orally, fiber-optic applicator with a diameter of 8 mm in contact mode intraorally, with a power density of 400 mW/cm2, delivering 10-12 J/cm2 on each application point, over a period of 20 sec.

There are two methods for examination of lateral pterygoid muscle: digital palpation and functional manipulation.

For digital palpation of lateral pterygoid muscle, we place our index finger or tip of our little finger in the vestibular area adjacent to the maxillary third molar.

Functional manipulation of the inferior head of lateral pterygoid muscle: It is best accomplished by having the patient make a protrusive movement against resistance to contract it since this muscle is the primary pro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain: will be obtained by Visual analogue scale (VAS).
Time Frame: pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Pain: will be obtained by Visual analogue scale (VAS).
pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth opening, lateral protrusive movement: will be obtained by a caliper.
Time Frame: Mouth opening, lateral protrusive movement will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Mouth opening, lateral protrusive movement: will be obtained by a caliper.
Mouth opening, lateral protrusive movement will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clicking: will be obtained by Yes or No.
Time Frame: Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7.after 3 months.
Clicking: will be obtained by Yes or No.
Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7.after 3 months.
Clicking: will be obtained by Yes or No.
Time Frame: Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Clicking: will be obtained by Yes or No.
Clicking will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

May 9, 2025

First Submitted That Met QC Criteria

May 22, 2025

First Posted (Actual)

May 31, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment of TMD by laser

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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