NCT06044974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

September 13, 2023

Last Update Submit

July 30, 2024

Conditions

Temporomandibular Joint Disorders

Keywords

TMDLaserEGFsalivapain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    baseline, and 4, 12 weeks

  • Maximum unassisted opening

    baseline, 7, 14, 21 days, and 4, 12 weeks.

  • Pain Free Opening

    baseline, 7, 14, 21 days, and 4, 12 weeks.

  • Salivary levels of glutamate

    baseline, and 4, 12 weeks

  • Salivary levels of Nerve growth factor

    baseline, and 4, 12 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

Nd-YAG FotonaDEVICE

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

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

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

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Alexandria Governorate, Egypt

Location

Related Publications (1)

  • Qataya PO, Zaki AM, Amin F, Swedan A, Elkafrawy H. Effect of Nd-YAG Laser Versus Epidermal Growth Factor Injection on Salivary Pain Mediators in Myogenic Temporomandibular Disorders (A Randomized Clinical Trial). J Oral Pathol Med. 2025 Nov;54(10):992-1000. doi: 10.1111/jop.70053. Epub 2025 Sep 2.

    PMID: 40891771DERIVED

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Interventions

Epidermal Growth Factor

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsEGF Family of ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups suffering from myogenic Tempromandibular disorders. Each group will receive either photobiomodulation using ND-YAG laser or injection of epidermal growth factor intramuscular.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

January 21, 2023

Primary Completion

August 10, 2023

Study Completion

January 10, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL
Time Frame
October 2023
Access Criteria
clinicaltrials.gov
More information

Locations

EG(1)