Alexandria University
Alexandria, Alexandria Governorate, Egypt
NCT Number: NCT06044974
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 4
Alexandria, Alexandria Governorate, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
four combined therapy sessions using 1064 nm Nd-YAG laser (once/week)
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
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.
Time frame: 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.
Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.
Maximum unassisted opening even if associated with pain measured in mm or cm
Time frame: baseline, 7, 14, 21 days, and 4, 12 weeks.
Pain free opening measured in mm or cm
Time frame: baseline, and 4, 12 weeks
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Time frame: baseline, and 4, 12 weeks
Detection of salivary pain mediators using enzyme-linked immunosorbent assay (ELISA) technique
Alexandria University
Other
Piano Level Laser Therapy Versus Epidermal Growth Factor in the Treatment of Myogenic Tempromandibular Disorder (Randomized Clinical Trial)
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