Botulinum Toxin injection in different group of muscles for the management of TMJ myofacial pain.

Not Applicable

Active, not recruiting

• Conditions: Myofascial Pain - Dysfunction Syndrome of TMJ; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12623000132640
• Lead Sponsor: Damascus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Pain on palpation using visual analogue scale (VAS).[- Before injection<br>- After 2 weeks<br>- After 2 months<br>- After 4 months<br>- After 6 months (primary timepoint)];-Maximal opening mouth without pain. This will be measured by asking the patient to open their mouth as wide as possible without pain and measuring the distance between the edges of the central incisors with a caliper.<br>[- Before injection<br>- After 2 weeks<br>- After 2 months<br>- After 4 months<br>- After 6 months (primary timepoint)];-Plaque on the buccal surfaces of molars and premolars using Turesky Modified Quigley-Hein (TMQH) plaque index.[- Before BTA injection into masseter muscle.<br>- After 2 weeks.]

Secondary Outcome Measures

Name	Time	Method
Molars and premolars buccal surfaces mineralization. which will be assessed using Diagnodent.[- Before BTA injection into masseter muscle<br>- After one month of the injection.];- Unstimulated salivary flow rates. [- Before BTA injection into masseter muscle.<br>- After 2 weeks.];- Investigate changes in mandibular angle volume using cone beam computed tomography (CBCT) which will be taken for each patient before BTA injection and after 6 months of the injection.[- Before BTA injection.<br>- After 6 months.];- Investigate Changes in condyle using CBCT.[- Before BTA injection.<br>- After 6 months.];- Investigate changes in masseter muscle thickness using CBCT.[- Before BTA injection.<br>- After 6 months]