Intraoral Injection of Trigger Points by Botox

• Status: Enrolling by invitation
• Trial end date: 2023-02-25
• Target enrollment: 0
• Participant gender: All

Summary

Patients with orofacial pain lasting at least for 3 months .The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected BTA in each TrPs according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1-week, 4-weeks, and 6-weeks post-injection. The patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS). The secondary outcome assessed will be measuring the quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fayoum University
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria(9)

• the presence of one or more trigger points in the unilateral or bilateral masseter muscle -

• no history of any invasive procedures in the related masseter muscle

Exclusion Criteria:

• Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder).

• Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy

• pregnancy and lactation.