Intraoral Injection of Trigger Points by Botox

Fayoum University40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myofacial Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

pain score

The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.

Time frame: 6 weeks post injection

Secondary Outcomes

(OHIP-14) scale

OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items

Time frame: 6 weeks