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OpenTrials
Completed

NCT Number: NCT06327204

Efficacy of Different Low Level Laser Therapy Sessions

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, October 6 University

Cairo, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

940-nm diode laser / one session

Device

laser therapy using a 940-nm diode laser / one session per week

940-nm diode laser / two session

Device

laser therapy using a 940-nm diode laser / two session per week

940-nm diode laser/ three session

Device

laser therapy using a 940-nm diode laser / three session per week

Primary outcomes

  1. pain score

    Time frame: 8 weeks

    a 10-point visual analogue score

Secondary outcomes

  1. maximum mouth opening

    Time frame: 8 weeks

    measuring the interincisal distance between the upper and lower central incisors

  2. 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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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