Temporomandibular Joint DisordersPhase 4NCT06044974
Nd-YAG Laser Versus Epidermal Growth Factor For Myogenic Tempromandibular Disorder.
A Phase 4 study testing Nd-YAG Fotona and Epidermal Growth Factor in people with Temporomandibular Joint Disorders, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Nd-YAG Fotona and Epidermal Growth Factor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2023to 10 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Nd-YAG Fotona, Epidermal Growth Factor
- Keywords
- TMD, Laser, EGF, saliva, pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd-YAG FotonaDevice
four 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Epidermal Growth Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: baseline, and 4, 12 weeks
Maximum unassisted opening
Maximum unassisted opening even if associated with pain measured in mm or cm
Measured: baseline, 7, 14, 21 days, and 4, 12 weeks.
Pain Free Opening
Pain free opening measured in mm or cm
Measured: 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
Measured: baseline, and 4, 12 weeks
Salivary levels of Nerve growth factor
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Measured: baseline, and 4, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start21 Jan 2023
- Primary completion10 Aug 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passant Osama Qataya, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044974
- Sponsor's protocol ID
- Ndyag laser december 2022
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Publications
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.
PubMed 40891771
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piano Level Laser Therapy Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06044974
- Acronym / sponsor ID
- Ndyag laser december 2022
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- TMD, Laser, EGF, saliva, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I (n=15): combined therapy sessions using 1064 nm Nd-YAG laser (once/week) | Active comparator | Device: Nd-YAG FotonaEach 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. |
| Group II (n=15): Epidermal Growth factor (EGF) injection | Active comparator | Drug: Epidermal Growth FactorEpidermal 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nd-YAG Fotonafour combined therapy sessions using 1064 nm Nd-YAG laser (once/week) | Device | Group I (n=15): combined therapy sessions using 1064 nm Nd-YAG laser (once/week) |
| Epidermal Growth FactorEpidermal 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 | Drug | Group II (n=15): Epidermal Growth factor (EGF) injection |
Primary outcome
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.
5 secondary outcomes
Quality of Life using Oral Health Impact Profile (OHIP)-14 questionnaire
Time frame: baseline, and 4, 12 weeks
Maximum unassisted opening
Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.
Pain Free Opening
Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.
Salivary levels of glutamate
Time frame: baseline, and 4, 12 weeks
Salivary levels of Nerve growth factor
Time frame: baseline, and 4, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40891771Qataya 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.
- Individual participant dataSharing planned: Yes. study protocol
Related trials for Temporomandibular Joint Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nd-YAG Fotona and Epidermal Growth Factor in people with Temporomandibular Joint Disorders, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (Numerical Rating Scale) (time frame: Pain will be measured at baseline, 7,14,21 days, and 4, 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.