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

Cairo University (CU)

Status: Enrolling

Conditions: Pain, Face; Temporomandibular Joint Dysfunction Syndrome

Treatments: Device: Soft occlusive splint; Other: Low level laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04831346

CairoU2020

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

low level laser

Experimental group

Description:

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)

Treatment:

Other: Low level laser

Occlusive splint therapy

Experimental group

Description:

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.

Treatment:

Device: Soft occlusive splint

Control

No Intervention group

Description:

This group will be a wait list group recieving no intervention except for the regular analgesic prescribed by the reffering dentist