Back to resultsEfficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders (RCT)
Primary Purpose
Temporomandibular Joint Dysfunction Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low Level LASER therapy
Hard occlusal splint
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring Low level LASER therapy, Michigan splint, Electromyogram, Myofascial pain
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).
Sites / Locations
- faculty of dentistry, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LASER group
Splint group
Arm Description
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), 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.
Outcomes
Primary Outcome Measures
Electromyographic muscle activity
The change in muscle activity was assessed using EMG in terms of Microvolt
Range of mandibular movement
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
Secondary Outcome Measures
Pain intensity
The degree of pain is assessed using a 10 cm scale (VAS)
Mouth opening
degree of mouth opening in cm using ruler
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05901701
Brief Title
Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders
Acronym
RCT
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
May 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome
Keywords
Low level LASER therapy, Michigan splint, Electromyogram, Myofascial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
Masking
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.
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LASER group
Arm Type
Experimental
Arm Description
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.
Arm Title
Splint group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Low Level LASER therapy
Intervention Description
using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.
Intervention Type
Device
Intervention Name(s)
Hard occlusal splint
Other Intervention Name(s)
Michigan splint
Intervention Description
2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.
Primary Outcome Measure Information:
Title
Electromyographic muscle activity
Description
The change in muscle activity was assessed using EMG in terms of Microvolt
Time Frame
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Title
Range of mandibular movement
Description
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
Time Frame
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Secondary Outcome Measure Information:
Title
Pain intensity
Description
The degree of pain is assessed using a 10 cm scale (VAS)
Time Frame
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Title
Mouth opening
Description
degree of mouth opening in cm using ruler
Time Frame
Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami M Ghali, professor
Organizational Affiliation
oral and maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amany M Farahat, PhD
Organizational Affiliation
Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dina E Bahig, PhD
Organizational Affiliation
Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of dentistry, Ain Shams University
City
Cairo
ZIP/Postal Code
11766
Country
Egypt
12. IPD Sharing Statement
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Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders
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