Intraoral Injection of Trigger Points by Botox

Phase 2

• Conditions: Myofacial Pain
• Interventions: Drug: intraoral trigger point injection by botox; Drug: transcutaneous trigger point injection by botox

• Registration Number: NCT05673655
• Lead Sponsor: Fayoum University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-25
• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-06
• Last Update Submitted: 2023-01-07
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraoral injection	intraoral trigger point injection by botox	-
transcutaneous injection	transcutaneous trigger point injection by botox	-

Primary Outcome Measures

Name	Time	Method
pain score	6 weeks post injection	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.

Secondary Outcome Measures

Name	Time	Method
(OHIP-14) scale	6 weeks	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

Trial Locations

Locations (1)

Fayoum University; 🇪🇬 Fayoum, Egypt