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Completed

NCT Number: NCT05901701

Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

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.

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Key information

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Ain Shams University

Cairo, 11766, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Hard occlusal splint

Device

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

Other names: Michigan splint

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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