Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders

• ClinicalTrials.gov Identifier: NCT04831346
• Recruitment Status: Recruiting
• First Posted: April 5, 2021
• Last Update Posted: April 6, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Tamer Mohamed Shousha, Cairo University

Study Description

Brief Summary:

This is a one year followup study that aims to assess the efficacy of low level laser therapy (LLLT) on pain, mouth opening and masticatory muscle activity in cases of temporomandibular dysfunction (TMD) as compared to soft occlusive splints.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Joint Dysfunction Syndrome; Pain, Face	Other: Low level laser; Device: Soft occlusive splint	Not Applicable

Detailed Description:

A prospective, parallel randomized, controlled study will be conducted at the outpatient university clinic. Participant recruitment started following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection. Per inclusion criteria, subjects included are females less than 30 years of age, diagnosed with unilateral arthrogenous TMD, having complete permanent dentition and showing normal occlusion. Prior to participating in any study-related procedures, participants read and signed the informed consent form approved by the Institutional Review Board. Participants will be divided into three groups; three groups: LLLT (Group A); soft occlusive splint therapy OST (Group B); waitlist as controls (Group C).

Outcome measures: TMJ opening index (TOI), VAS, sEMG. Participants were not given information on which treatment they were receiving; they were only told that they could receive one of two different treatment techniques. Sessions were scheduled 3 days a week (every other day) for a total of 10 sessions

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assignment A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received low level laser therapy (gallium arsenide diode ) while the other received the soft occusive splint. The control group was considered as a wait list for laser treatment aand did not recieve any treatment during the intervention period.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The participants as well as The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention.
• Primary Purpose: Treatment
• Official Title: Effects of Low-Level Laser Therapy Versus Soft Occlusive Splints on Mouth Opening and Surface Electromyography in Temporomandibular Disorders
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: November 1, 2021
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: low level laser; A low-level gallium arsenide diode (Biolase, USA) at a 940 nm wavelength with 0.2 W output power and 2 J energy. The device was calibrated, and the probe was disinfected prior to every treatment. The Masseter and Temporalis muscles will be bilaterally assessed with constant pressure to define tenderness. LLLT applied perpendicular to each tender point of the intended muscles for 10 seconds with an energy density of 2.5 J/cm2. Sessions are scheduled 3 days a week (every other day)	Other: Low level laser; 940 nm wavelength with 0.2 W output power and 2 J energy applied for 10 seconds with an energy density of 2.5 J/cm2.; Other Name: A low-level gallium arsenide diode
Experimental: Occlusive splint therapy; A soft occlusal splint (vacuum-formed ) made from a 2-mm-thick elastic rubber sheets will be used. Splints were individually designed ( in the out patient clinic of the college of dentistry) for the upper arch of each patient. An alginate imprint of the maxillary arch will be taken to fabricate a master cast of the maxilla. A vacuum pressure device was utilized for molding the rubber sheets (13 x 13 cm /2-mm thickness). Sheets were removed after it has been appropriately adjusted to the mold in the vacuum former. Edges will be properly trimmed, and the palate part is detached to obtain the end shape. Participants are instructed to wear the splint at all times except during mealtimes and oral hygiene.	Device: Soft occlusive splint; A vacuum-formed soft occlusal splint made from a 2-mm-thick elastic rubber sheets. Participants are instructed to always wear the splint except during mealtimes and oral hygiene.
No Intervention: Control; This group will be a wait list group recieving no intervention except for the regular analgesic prescribed by the reffering dentist

Outcome Measures

Primary Outcome Measures :

1. Change in the Temporomandibular joint opening index (TOI): [ Time Frame: baseline (pre-treatment) / after 3 weeks / and after 1 year ]

   Active and passive mouth opening will be assessed by a Boley gauge (Electronic Digital Caliper, CE Company, Japan)

   TOI= Passive opening mm -Maximum voluntary opening mm X 100 Passive opening mm +Maximum voluntary opening mm

Secondary Outcome Measures :

1. change in surface EMG (sEMG): [ Time Frame: baseline (pre-treatment) / after 3 weeks / and after 1 year ]

   For recording, a surface electromyograph (Myotronics-Noromed, Inc., Tukwila WA, USA), with 8-channels, simultaneous acquisition, common grounding to all channels, and filters of 50 Hz electromyography with disposable electrodes will be used.

   Subjects will be seated on chairs with back and head rests to allow assessment from a relaxed position.

   The right masseter (RM), left masseter (LM), right anterior temporal (RAT), left anterior temporal (LAT), right sternocleidomastoid (RSM), and left sternocleidomastoid (LSM) muscles were recorded. The sEMG recordings and muscle activity will be expressed as the root mean square (rms) of the amplitude, expressed in µV.

2. Change in Visual Analogue Scale (VAS) [ Time Frame: baseline (pre-treatment) / after 3 weeks / and after 1 year ]

   The pain VAS is a reliable measure of pain intensity with a 10 centimeters (100 mm) continuous scale attached by 2 verbal descriptors, one for each symptom extreme.

   For pain intensity, the scale is most anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100).

   The VAS only requires the ability to use a ruler to measure the distance to determine a score.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Females less than 30 years of age, Diagnosed with unilateral myogenous TMD, Having complete permanent dentition Showing normal occlusion

Exclusion Criteria:

Prior experience of Laser therapy, Systemic diseases (rheumatoid arthritis, ankylosing spondylitis, diabetes… etc. History of trauma in the TMJ or cervical regions; Neurological disorders, Muscular diseases; Cervical pain; Bruxism, Pregnancy; Currently on medication (analgesic, anti-inflammatory, muscle relaxants or anti- depressants) Current use of dental prosthetics; Previous orthodontal treatments; or Fixed restorations affecting occlusal surfaces.

Contacts and Locations

Contacts

Contact: Tamer Shousha, Lecturer; 002-01227900667; shoushadoc@yahoo.com

Locations

Egypt

Faculty of Physical Therapy; Recruiting

Giza, Egypt, 11432

Contact: Tamer Shousha, Lecturer 002-01227900667 shoushadoc@yahoo.com

Contact: Alaa Balbaa, Professor 002-01005167796 balbaaa@hotmail.com

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Tamer Shousha; Lecturer

More Information

• Responsible Party: Tamer Mohamed Shousha, Lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT04831346
• Other Study ID Numbers: CairoU2020
• First Posted: April 5, 2021
• Last Update Posted: April 6, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: no plan to make individual participant data (IPD) available to other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tamer Mohamed Shousha, Cairo University:

Temporomandibular; Dysfunction; VAS; EMG; Laser

Additional relevant MeSH terms:

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases; Facial Pain; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes; Pain; Neurologic Manifestations