Efficacy of Different Low Level Laser Therapy Sessions

March 20, 2024 updated by: Amany Ahmed AlAraby, October 6 University

Efficacy of Different Low Level Laser Therapy Sessions in Management of Masseter Muscle Trigger Points

Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 21523
        • Faculty of Dentistry, October 6 University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
  2. presence of one or more trigger points in the masseter muscle
  3. no history of any invasive procedures of the related masseter muscle.

Exclusion Criteria:

  1. any painful conditions affecting the orofacial region
  2. any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
  3. pregnancy and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
patient received one session / week
Device: 940-nm diode laser / one session
laser therapy using a 940-nm diode laser / one session per week
Active Comparator: group II
patient received two session / week
Device: 940-nm diode laser / two session
laser therapy using a 940-nm diode laser / two session per week
Active Comparator: Group III
Patient received three session / week
Device: 940-nm diode laser/ three session
laser therapy using a 940-nm diode laser / three session per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 8 weeks
a 10-point visual analogue score
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum mouth opening
Time Frame: 8 weeks
measuring the interincisal distance between the upper and lower central incisors
8 weeks
quality of life questioner
Time Frame: 8 weeks
Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Principal Investigator: amany Ahmed, PhD, faculty of dentistry, October 6 University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low Level laser 24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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