Health TrialsbyHealthPanel

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

ConditionsTemporomandibular Joint Dysfunction SyndromePain, Face
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low level laser

    Other intervention

    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.

  • Soft occlusive splint

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: low level laserExperimental treatment 1 intervention
Group B: Occlusive splint therapyExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in the Temporomandibular joint opening index (TOI):

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

Time frame
baseline (pre-treatment) / after 3 weeks / and after 1 year

Secondary outcomes

1

change in surface EMG (sEMG):

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.

Time frame
baseline (pre-treatment) / after 3 weeks / and after 1 year
2

Change in Visual Analogue Scale (VAS)

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.

Time frame
baseline (pre-treatment) / after 3 weeks / and after 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
Apply now