The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:
* which treatment has longer effect of pain release with the least possible side effects and recurrence rate? * Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times * 1st visit will include taking preoperative records and treatment injection * 2nd visit will be follow up and taking records after 1 month * 3rd visit will be follow up and taking records after 3 months * 4th visit will be follow up and taking records after 6 months
Patients diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria
Definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
Presence of one or more unilateral or bilateral trigger points in the masseter muscle
No history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)
Any painful conditions (other than myofascial trigger points) affecting the orofacial region
Any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy
Pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)
Parallel
MgSO4
Drug2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).
BOTOX-A
Drug2ml of BTX
Saline (NaCl 0,9 %) (placebo)
Drug2 ml of saline
Evaluating pain
Pain will be recorded with a visual analog scale (VAS of 0-10, with zero being no pain and 10 the worst pain possible)
Pain-free maximum mouth opening (MMO)
Pain-free MMO will be measured as the distance between the incisal edges of the upper and lower incisors. Three measurements will be performed, and their average was recorded (Taşkesen, Cezairli, 2023).
Muscle health and activity measured using electromyography
Muscle health and activity measured using electromyography, EMG can provide valuable insights into altered muscle activity patterns and help in the diagnosis and management of MPDS through readings (Zieliński, et al, 2021).
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14)
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health. The participant will be asked to score each question using a scale from 1 to 5 \[never (score 0); hardly ever (score 1); occasionally (score 2); fairly often (score 3); and very often (score 4)\], and the sum of all 14 items was calculated. The OHIP score could range from 0 to 56 units, with the former indicating no problems and higher scores representing greater impairment of quality of life (Slade and Spencer, 1994).
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