Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders (RCT)

June 4, 2023 updated by: Ain Shams University

Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial

This study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

56 female patients were randomly divided into two groups, Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected from TMJ problems. The opening measurements of the patient were taken using a millimeter ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS) was used to evaluate the pain intensity. All was done before the beginning of the treatment at three and six months follow up period.

Study Type

Interventional

Enrollment (Actual)

56

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 Locations

  • Egypt
      • Cairo, Egypt, 11766
        • faculty of dentistry, Ain shams university

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: tenderness in the TMJ or muscles of mastication (e.g., temporalis and masseter) that might get worse in the morning or with eating, headache, periauricular pain, teeth wear that appears in the form of multiple smooth shinny facets, teeth mobility, and malocclusion

Exclusion Criteria:

  • pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., Rheumatoid arthritis, psychiatric disorders, skeletal morphology as class II or III, TMJ clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as Muscle relaxant, Steroids, Dopamine precursors like L dopa and Aminoglycoside
  • Vulnerable groups (prisoners, mental disorders, patients not capable of decision making).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LASER group
Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.
Radiation: Low Level LASER therapy
using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.
Active Comparator: Splint group
Group B: Patients received hard occlusal splints (Michigan splints), used for 3 months during sleeping then the patient stops using it and told to only wear it if discomfort return usually during stressful times.
Device: Hard occlusal splint
2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.
Other Names:
  • Michigan splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyographic muscle activity
Time Frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The change in muscle activity was assessed using EMG in terms of Microvolt
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Range of mandibular movement
Time Frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The degree of pain is assessed using a 10 cm scale (VAS)
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Mouth opening
Time Frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
degree of mouth opening in cm using ruler
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Rami M Ghali, professor, Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
  • Principal Investigator: Amany M Farahat, PhD, Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
  • Principal Investigator: Dina E Bahig, PhD, Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams 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 (Actual)

November 20, 2022

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

May 27, 2023

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 4, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 4, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-Rec IR112207

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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