Temporomandibular Joint Disorders
Conditions
Keywords
TMD, Laser, EGF, saliva, pain
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.
Interventions
DEVICENd-YAG Fotona
four combined therapy sessions using 1064 nm Nd-YAG laser (once/week)
DRUGEpidermal 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
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (Numerical Rating Scale) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life using Oral Health Impact Profile (OHIP)-14 questionnaire | baseline, and 4, 12 weeks | 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. |
| Maximum unassisted opening | baseline, 7, 14, 21 days, and 4, 12 weeks. | Maximum unassisted opening even if associated with pain measured in mm or cm |
| Pain Free Opening | baseline, 7, 14, 21 days, and 4, 12 weeks. | Pain free opening measured in mm or cm |
| Salivary levels of glutamate | baseline, and 4, 12 weeks | Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique |
| Salivary levels of Nerve growth factor | baseline, and 4, 12 weeks | Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique |
Countries
Egypt
Outcome results
None listed