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Enrolling By Invitation
NCT05673655
Intraoral Injection of Trigger Points by Botox
Conditions: Myofacial Pain
Sex: All
Ages: 18 Years – 60 Years
Phase: PHASE2
Enrollment: 40
Sponsor: Fayoum University
Location: Egypt
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).
Eligibility Criteria
Inclusion Criteria:Definite diagnosis of myofascial pain with a referralthe presence of one or more trigger points in the unilateral or bilateral masseter muscle -no history of any invasive procedures in the related masseter muscleExclusion Criteria:Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsypregnancy and lactation.
Source: ClinicalTrials.gov (NCT05673655). StuddyBuddy aggregates publicly available trial information.