NCT06772012

Brief Summary

This study will investigate if Low-Level Laser Therapy (LLLT) is more effective than Orofacial Physical Therapy for treating Temporomandibular Dysfunction. By conducting a randomized controlled trial, it aims to fill gaps in current knowledge, improve TMD treatment options, and enhance patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 8, 2025

Last Update Submit

January 8, 2025

Conditions

Temporomandibular Dysfunction

Keywords

temporomandibular dysfunction

Outcome Measures

Primary Outcomes (1)

  • jaw range of motion

    6 weeks

Study Arms (2)

Low-Level Laser Therapy (LLLT)

EXPERIMENTAL

Intervention Protocol: * Frequency: LLLT was administered 3 times per week. * Duration: Each session lasted approximately 15-20 minutes. * Total Duration: The therapy was provided for a total of 6 weeks.(50)

Other: Low-Level Laser Therapy (LLLT)

Orofacial Physical Therapy

ACTIVE COMPARATOR

Intervention Protocol: * Frequency: Orofacial physical therapy sessions were conducted 3 times per week. * Duration: Each session lasted around 30-40 minutes. * Total Duration: The therapy was provided for a total of 6 weeks. * Components: * Manual Therapy: Included techniques such as joint mobilization, soft tissue manipulation, and muscle stretching. * Therapeutic Exercises: Focused on strengthening, coordination, and improving mobility of the masticatory muscles. * Postural Training: Addressed poor posture and cervical muscle spasm.(50)

Other: Orofacial Physical Therapy

Interventions

Low-Level Laser Therapy (LLLT)OTHER

* Frequency: LLLT was administered 3 times per week. * Duration: Each session lasted approximately 15-20 minutes. * Total Duration: The therapy was provided for a total of 6 weeks.(50)

Low-Level Laser Therapy (LLLT)
Orofacial Physical TherapyOTHER

* Frequency: Orofacial physical therapy sessions were conducted 3 times per week. * Duration: Each session lasted around 30-40 minutes. * Total Duration: The therapy was provided for a total of 6 weeks. * Components: * Manual Therapy: Included techniques such as joint mobilization, soft tissue manipulation, and muscle stretching. * Therapeutic Exercises: Focused on strengthening, coordination, and improving mobility of the masticatory muscles. * Postural Training: Addressed poor posture and cervical muscle spasm.(50)

Orofacial Physical Therapy

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) limited mouth opening or function(49) 2) presence of pain in masticatory muscles and/or TMJs(49) 3) muscular disturbance (49) 4) arthralgia(49)

You may not qualify if:

  • \) major systemic disorders (49) 2) who received analgesic or anti-depressants over the last 2 weeks(49) 3) had any bony abnormalities of the jaws (49) 4) psychological illness (49) 5) pregnant and feeding women (49)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria University

Karachi, 75500, Pakistan

Location

Related Publications (1)

  • Petrucci A, Sgolastra F, Gatto R, Mattei A, Monaco A. Effectiveness of low-level laser therapy in temporomandibular disorders: a systematic review and meta-analysis. J Orofac Pain. 2011 Fall;25(4):298-307.

    PMID: 22247925BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 13, 2025

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

December 2, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)