NCT05673655

Intraoral Injection of Trigger Points by Botox

Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fayoum University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Patients with orofacial pain lasting at least 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 Botox at each trigger point 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, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).

Conditions

• Myofacial Pain

Interventions

Type	Name	Description
DRUG	intraoral trigger point injection by botox	intraoral injection of trigger point of masseter muscle by botulinum toxin
DRUG	transcutaneous trigger point injection by botox	transcutaneous injection of masseter muscle by botulinum toxin

Timeline

• Start date: 2022-12-25
• Primary completion: 2023-02-01
• Completion: 2023-02-25
• First posted: 2023-01-06
• Last updated: 2023-01-10

Locations

1 site across 1 country: Egypt