Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901701
• Other study ID #: FDASU-Rec IR112207
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: May 27, 2023

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 27, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Joint Diseases
• Muscular Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

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

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Pain intensity	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)
Secondary	Mouth opening	degree of mouth opening in cm using ruler	Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)