None listed
Conditions
Brief summary
The primary purpose of this study is to compare the efficacy of Botulinum toxin type A (BTA) injection into masseter muscles alone versus injection of the same amount of BTA into lateral pterygoid and temporalis muscles for the management of patients with myofacial pain and bruxism. Mandibular movements during bruxism include open-close, lateral and anterior-posterior moves. These movements will be reduced when BTA is injected into lateral pterygoid and temporalis muscles. On the other hand, when BTA is injected into the masseter muscles, only the closing movement will be affected. Thus the main null hypothesis for this study is that there is no difference between the injection of BTA into masseter muscles or lateral pterygoid and temporalis muscles. We also aim to investigate the morphological changes in the condyle, mandibular angle, and masseter muscle volume using CBCT. Furthermore, the effect of BTA injection into masseter muscles on saliva, plaque formation, and teeth mineralization will be studied.
Interventions
The treatment will be administered by the main researcher at the study clinic. Botulinum toxin type A (BTA) will be reconstituted with normal saline to 5 units/0.1 mL. BTA will be injected bilaterally into the lateral pterygoid and temporalis muscles.
Five units of BTA will be injected in each group of temporalis muscle fibers, the anterior, middle, and posterior fibers, in a total dose of 15 units per muscle. 10 Units of BTA will be injected intraorally in each lateral pterygoid muscle using p
The treatment will be administered by the main researcher at the study clinic. Botulinum toxin type A (BTA) will be reconstituted with normal saline to 5 units/0.1 mL. BTA will be injected bilaterally into the lateral pterygoid and temporalis muscles. Five units of BTA will be injected in each group of temporalis muscle fibers, the anterior, middle, and posterior fibers, in a total dose of 15 units per muscle. 10 Units of BTA will be injected intraorally in each lateral pterygoid muscle using pre-sterilized disposable injectable monopolar needle electrodes for EMG 37mm x 26ga (Chalgren Enterprises Inc, USA). The needle will be inserted at the mucobuccal fold of the distal root of the upper second molar. The angulation of the inserted needle will be posteriorly and superiorly by 30 degrees with the occlusal plane and 20 degrees medially. The depth of insertion will be between 20 to 30 mm. Before injection, the syringe will be aspirated to ensure the needle has not pierced a blood vessel. Using an electromyography appliance (Micromed, Italy), the correct electrode placement will be verified by evaluating the full recruitment of electromyographic signal during contralateral mandibular movement. In addition, 0.5 mL of normal saline will be injected into each masseter muscle as a placebo. Each participant will only need to attend 1 x 30 min session of treatment. A study team member will monitor adherence to the intervention using a checklist.
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
- Patients with myofacial pain according to RDC-TMD axis I. -The pain intense on VAS is more than 5. - Bruxism. - Mild teeth wear include the centrals and canines. - Limited mouth opening due to muscles spasm.
Exclusion criteria
- Patients known to be allergic to any botulinum toxin. - Patients who underwent any botulinum toxin type A treatment in less than six months - Pregnant or breastfeeding women. - Patients addicted to narcotic drugs or alcohol. - Patients with depression and/or somatization according to RDC-TMD axis II. - People with neurological disorders. - Patients taking aminoglycosides. - Active infection at the injection site.
Outcome results
None listed