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

NCT ID: NCT04831346

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2025-02-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Temporomandibular Joint Dysfunction Syndrome Pain, Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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)

Group Type EXPERIMENTAL

Low level laser

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Soft occlusive splint

Intervention Type DEVICE

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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A low-level gallium arsenide diode

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Mohamed Shousha

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamer Shousha

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Faculty of Physical Therapy

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Tamer Shousha, Lecturer

Role: CONTACT

002-01227900667

Facility Contacts

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Tamer Shousha, Lecturer

Role: primary

002-01227900667

Alaa Balbaa, Professor

Role: backup

002-01005167796

Other Identifiers

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CairoU2020

Identifier Type: -

Identifier Source: org_study_id

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