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Clinical Trials in Egypt / NCT06676475
Starting soon Phase 2/3

Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle

NCT06676475 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2/3
Started
2024-12-01
Last updated
2024-11-12

Condition(s) studied

Myofacial PainTrigger Points, Myofascial

Investigational drug(s) / intervention(s)

MgSO4 →BOTOX-ASaline (NaCl 0,9 %) (placebo)

MgSO4: 2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).

BOTOX-A: 2ml of BTX

Saline (NaCl 0,9 %) (placebo): 2 ml of saline

Study summary

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

Eligibility

Sex
ALL
Min age
16 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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.) Exclusion Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Misr university for science and technology Giza Egypt

More Misr University for Science and Technology trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676475 on ClinicalTrials.gov ↗ ← All trials in Egypt