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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Device: Nd-YAG Fotona; Drug: Epidermal Growth Factor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • الإسكندرية
    • Alexandria, الإسكندرية, Egypt
      • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients, both males and females, 20 years and older will be included in this clinical trial.
2. 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)
3. Patients suffering of unilateral or bilateral chronic pain (> 3 months duration) related to masseter and temporalis muscles (29)
4. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (n=15): combined therapy sessions using 1064 nm Nd-YAG laser (once/week); Each treatment session will include: a first pass, which will be performed using "cold" Piano Level Laser Therapy "PLLT" settings for photo biomodulation - MSP pulse (100 µs), P = 2W, 10 Hz, with 1 minute treatment duration per spot. A second pass, higher "warm" PLLT settings that causes mild heating of the tissue, aimed at pain relief - MSP pulses 5 W, 60 Hz, where the handpiece will be held at each spot from 30 seconds to 1 minute, depending on patient heat tolerance . Both the masseter and temporalis muscles will be divided into 3 spots: insertion, body, and origin for the masseter muscle and anterior, middle, and posterior for temporalis muscle. A stamping technique will be carried out for both passes.	Device: Nd-YAG Fotona; four combined therapy sessions using 1064 nm Nd-YAG laser (once/week)
Active Comparator: Group II (n=15): Epidermal Growth factor (EGF) injection; Epidermal Growth factor (EGF) injection 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; For masseter muscle injection, 3-point injection technique will be followed: 1 injection point in each zone. For temporalis muscle injection, 3-point injection technique will be followed: 1 in each zone; Each point will receive 0.1 ml of EGF	Drug: Epidermal Growth Factor; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (Numerical Rating Scale)	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.	Pain will be measured at baseline, 7,14,21 days, and 4, 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum unassisted opening	Maximum unassisted opening even if associated with pain measured in mm or cm	baseline, 7, 14, 21 days, and 4, 12 weeks.
Pain Free Opening	Pain free opening measured in mm or cm	baseline, 7, 14, 21 days, and 4, 12 weeks.
Salivary levels of glutamate	Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique	baseline, and 4, 12 weeks
Salivary levels of Nerve growth factor	Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique	baseline, and 4, 12 weeks
Quality of Life using Oral Health Impact Profile (OHIP)-14 questionnaire	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.	baseline, and 4, 12 weeks

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: pain; TMD; Laser; saliva; EGF
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: Ndyag laser december 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol
• IPD Sharing Time Frame: October 2023
• IPD Sharing Access Criteria: clinicaltrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No