Clinical trial NCT05901701: Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders
Official title: Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Low level LASER therapy
Michigan splint
Electromyogram
Myofascial pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Electromyographic muscle activity
timeFrame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
measure: Range of mandibular movement
timeFrame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Secondary outcomes:
measure: Pain intensity
timeFrame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
measure: Mouth opening
timeFrame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Ain Shams University
Study officials:
affiliation: oral and maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
name: Rami M Ghali, professor
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
name: Amany M Farahat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
name: Dina E Bahig, PhD
role: PRINCIPAL_INVESTIGATOR
References: