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Nd-YAG Laser Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)

Primary Purpose

Temporomandibular Joint Disorders

Status
Enrolling by invitation
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nd-YAG Fotona
Epidermal Growth Factor
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring TMD, Laser, Epidermal growth factor, Saliva, pain mediators.

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) . . 8 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 milletus, 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

Sites / Locations

  • Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I (n=15): combined therapy sessions using 1064 nm Nd-YAG laser (once/week)

Group II (n=15): Epidermal Growth factor (EGF) injection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pain Score (Numerical Rating Scale)
Subjective Pain score as measured by Numerical Rating Scale (NRS)

Secondary Outcome Measures

Quality of Life using OHIP-14 questionnaire
Quality of life questionnaire using OHIP-14 questionnaire
Maximum unassisted opening
Maximum unassisted opening even if associated with pain measured in mm or cm
Pain Free Opening
Pain free opening measured in mm or cm
Salivary levels of glutamate
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Salivary levels of Nerve growth factor
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT06044974
Brief Title
Nd-YAG Laser Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)
Official Title
Piano Level Laser Therapy Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
TMD, Laser, Epidermal growth factor, Saliva, pain mediators.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two groups suffering from myogenic Tempromandibular disorders. Each group will receive either photobiomodulation using ND-YAG laser or injection of epidermal growth factor intramuscular.
Masking
Outcomes Assessor
Masking Description
Data assessors: oral medicine co-worker and biochemist specialist, and statistician will all be blinded to the treatment of each patient; a triple-blinded clinical trial. Patients and primary clinician will not be blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (n=15): combined therapy sessions using 1064 nm Nd-YAG laser (once/week)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group II (n=15): Epidermal Growth factor (EGF) injection
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Nd-YAG Fotona
Intervention Description
four combined therapy sessions using 1064 nm Nd-YAG laser (once/week)
Intervention Type
Drug
Intervention Name(s)
Epidermal Growth Factor
Intervention Description
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 Outcome Measure Information:
Title
Pain Score (Numerical Rating Scale)
Description
Subjective Pain score as measured by Numerical Rating Scale (NRS)
Time Frame
Pain will be measured at baseline, 7,14,21 days, and 4, 12 weeks.
Secondary Outcome Measure Information:
Title
Quality of Life using OHIP-14 questionnaire
Description
Quality of life questionnaire using OHIP-14 questionnaire
Time Frame
baseline, and 4, 12 weeks
Title
Maximum unassisted opening
Description
Maximum unassisted opening even if associated with pain measured in mm or cm
Time Frame
baseline, 7, 14, 21 days, and 4, 12 weeks.
Title
Pain Free Opening
Description
Pain free opening measured in mm or cm
Time Frame
baseline, 7, 14, 21 days, and 4, 12 weeks.
Title
Salivary levels of glutamate
Description
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Time Frame
baseline, and 4, 12 weeks
Title
Salivary levels of Nerve growth factor
Description
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Time Frame
baseline, and 4, 12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) . . 8 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 milletus, 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
Facility Information:
Facility Name
Alexandria University
City
Alexandria
State/Province
الإسكندرية
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol
IPD Sharing Time Frame
October 2023
IPD Sharing Access Criteria
clinicaltrials.gov
IPD Sharing URL
http://clinicaltrials.gov

Learn more about this trial

Nd-YAG Laser Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)

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