Intraoral Injection of Trigger Points by Botox

Fayoum University

Status and phase

Invitation-only

Phase 2

Conditions

Myofacial Pain

Treatments

Drug: intraoral trigger point injection by botox

Drug: transcutaneous trigger point injection by botox

Study type

Interventional

Funder types

Other

Identifiers

NCT05673655

EC2213

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Definite diagnosis of myofascial pain with a referral
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 trigger points (decayed tooth, temporomandibular joint internal disorder).
Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
pregnancy and lactation.