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

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06044974
• Other study ID #: Ndyag laser december 2022
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 21, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: September 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 10, 2024
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

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3. Patients suffering of unilateral or bilateral chronic pain (> 3 months duration) related to masseter and temporalis muscles (29)

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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 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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria	??????????

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score (Numerical Rating Scale)	Subjective Pain score as measured by Numerical Rating Scale (NRS)	Pain will be measured at baseline, 7,14,21 days, and 4, 12 weeks.
Secondary	Quality of Life using OHIP-14 questionnaire	Quality of life questionnaire using OHIP-14 questionnaire	baseline, and 4, 12 weeks
Secondary	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.
Secondary	Pain Free Opening	Pain free opening measured in mm or cm	baseline, 7, 14, 21 days, and 4, 12 weeks.
Secondary	Salivary levels of glutamate	Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique	baseline, and 4, 12 weeks
Secondary	Salivary levels of Nerve growth factor	Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique	baseline, and 4, 12 weeks