Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

NCT05901701 | Completed

• 1 other identifier: FDASU-Rec IR112207
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Low level LASER therapy; Michigan splint; Electromyogram; Myofascial pain

Outcome Measures

Primary Outcomes (2)

• Electromyographic muscle activity

  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

  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 Outcomes (2)

• Pain intensity

  Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

• Mouth opening

  Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)

Study Arms (2)

LASER group

EXPERIMENTAL

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

Splint group

ACTIVE COMPARATOR

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

Interventions

Low Level LASER therapy RADIATION

using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.

LASER group

Hard occlusal splint DEVICE

2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.

Also known as: Michigan splint

Splint group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry, Ain Shams University

Cairo, 11766, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rami M Ghali, professor

  oral and maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blocked randomization technique was used to divide the patients into two equal groups using sealed envelopes, the person who was in charge for randomization was blinded to the group allocation of the patients. The outcome assessor also didn't know the allocated groups, and the patients were instructed not to mention their groups to the assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: November 20, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 27, 2023
• Last Updated: June 13, 2023

Record last verified: 2022-11

Locations

EG (1)