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Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05901701
Acronym
RCT
Enrollment
56
Registered
2023-06-13
Start date
2022-11-20
Completion date
2023-05-27
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

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

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.

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.

Interventions

RADIATIONLow 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.

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Electromyographic muscle activityMeasured 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
Range of mandibular movementMeasured 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.

Secondary

MeasureTime frameDescription
Pain intensityMeasured 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)
Mouth openingMeasured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)degree of mouth opening in cm using ruler

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026