NCT06999239

Brief Summary

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).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2025

Status
not yet 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 Progress78%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

May 9, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 9, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

laser therapy, lateral pterygoid muscle, Wilke's, stage I and II, TMD.

Outcome Measures

Primary Outcomes (1)

  • Pain: will be obtained by Visual analogue scale (VAS).

    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 Outcomes (1)

  • 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 Outcomes (2)

  • 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.

    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.

Study Arms (1)

one arm(case series0

EXPERIMENTAL
Procedure: laser therapy in TMD

Interventions

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

one arm(case series0

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

aliaa ibrahim fathy khalifa, B.D.S 2019

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 31, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06