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Completed

NCT Number: NCT06044974

Nd-YAG Laser Versus Epidermal Growth Factor For Myogenic Tempromandibular Disorder.

A clinical trial comparing the potential effect of 2 different modalities (Nd-YAG Laser Versus Epidermal growth factor injection) on pain reduction in patients suffering from myogenic tempromandibular disorder.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University

Alexandria, Alexandria Governorate, Egypt

About this study

Background: Tempromandibular disorders (TMDs) form a public health issue and are considered the second most common musculoskeletal problem (after chronic lower back pain) causing pain and disability. Myogenic TMD is one of the commonly prevalent TMDs with unclear pathophysiology. Central and peripheral sensitization are thought to play an evident role in development of myogenous TMD. Many treatment modalities have been proposed to eliminate pain, improve function and quality of life. Laser photobiomodulation has gained popularity in pain therapy and in treatment of chronic painful musculoskeletal disorders, among which are TMDs. Piano level laser therapy (PLLT) enables delivering different high intensities using large spot sizes and can be considered beneficial in the treatment of painful myogenic TMD.

Epidermal growth factor (EGF) has been found to repair muscle damage and increase muscle quality through direct promotion of proliferation and differentiation of muscle cells in addition to regulating the inflammatory response. EGF can be another minimally invasive treatment modality for chronic painful myogenic TMD. Glutamate and nerve growth factor (NGF) are considered neuropeptides associated with pain and hyperalgesia.

They have been related to painful TMD and have also been detected in saliva of patients suffering from chronically painful conditions including TMDs. Aim: The present study aims to evaluate and compare the effectiveness of Piano level laser therapy using 1064nm Nd-YAG laser and intramuscular EGF injection in pain alleviation, improvement of function and quality of life in patients suffering from myogenic temporomandibular disorder. The impact of these treatment modalities on levels of salivary glutamate and nerve growth factor pain mediators will also be investigated. Materials and Methods: A randomized clinical trial will be carried out on 30 patients suffering from chronic painful myogenic TMD based on diagnostic criteria for temporomandibular disorders (DC/TMD). Group I (n=15 patients) will be treated using 1064 nm Nd-YAG Laser: in 4 combined (cold=2W, warm=5W) laser therapy sessions (once/week) using stamping technique on masseter and temporalis muscles. Group II (n=15 patients) will be treated by intramuscular injection of EGF in masseter and temporalis muscles.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients, both males and females, 20 years and older will be included in this clinical trial.
  • Patients suffering from myogenic TMD (myogenic TMD/ Myofascial pain without referral/ Myofascial pain with referral) based on Diagnostic criteria for diagnosis of Tempromandibular joint disorders (DC/TMD) criteria (1)
  • Patients suffering of unilateral or bilateral chronic pain (> 3 months duration) related to masseter and temporalis muscles (29)
  • Patients that have not responded to conservative modes of treatment (analgesics, muscle relaxants, fomentation, splints ect.).

Exclusion criteria

  • Patients suffering from any condition that could alter pain sensitivity; neurological diseases, pain of dental origin, pregnancy or lactation, high blood pressure, diabetes mellitus, rheumatic inflammatory disease, fibromyalgia, obstructive sleep apnea, skin infection over injection areas related to masseter and temporalis muscles, and restrictions for the use of laser (pacemakers) (6, 20, 30) 2. Participants on medications that can affect pain sensitivity and pain perception; anticoagulants, analgesics, antidepressants during the last 2 weeks before the study (6, 20) 3. Smokers or those with conditions that could affect saliva collection or composition; hyposalivation, poor oral hygiene, periodontitis and oral mucosal diseases

Treatment and study plan

Nd-YAG Fotona

Device

four combined therapy sessions using 1064 nm Nd-YAG laser (once/week)

Epidermal Growth Factor

Drug

Epidermal growth factor "EGF-genesis" by Dermaquel Paris n into masseter and temporalis muscles. Each muscle will be divided into 3 zones; origin, body and insertion for masseter muscle, anterior, middle, and posterior for temporalis muscle

Primary outcomes

  1. Pain Score (Numerical Rating Scale)

    Time frame: Pain will be measured at baseline, 7,14,21 days, and 4, 12 weeks.

    Subjective Pain score as measured by Numerical Rating Scale (NRS) on a scale from "0" to "10", where "0" means no pain at all and "10" means worst response and maximum pain.

Secondary outcomes

  1. Quality of Life using Oral Health Impact Profile (OHIP)-14 questionnaire

    Time frame: baseline, and 4, 12 weeks

    Quality of life questionnaire using OHIP-14 questionnaire, a score from 0 to 14, where score "0" means best quality of life impact and score "14" means the worst impact on quality of life.

  2. Maximum unassisted opening

    Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.

    Maximum unassisted opening even if associated with pain measured in mm or cm

  3. Pain Free Opening

    Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.

    Pain free opening measured in mm or cm

  4. Salivary levels of glutamate

    Time frame: baseline, and 4, 12 weeks

    Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique

  5. Salivary levels of Nerve growth factor

    Time frame: baseline, and 4, 12 weeks

    Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Piano Level Laser Therapy Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Aug 1, 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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