Intraoral Injection of Trigger Points by Botox

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-25

Study Completion Date

2023-02-25

Brief Summary

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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).

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Detailed Description

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Conditions

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Myofacial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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transcutaneous injection

Group Type ACTIVE_COMPARATOR

transcutaneous trigger point injection by botox

Intervention Type DRUG

transcutaneous injection of masseter muscle by botulinum toxin

intraoral injection

Group Type ACTIVE_COMPARATOR

intraoral trigger point injection by botox

Intervention Type DRUG

intraoral injection of trigger point of masseter muscle by botulinum toxin

Interventions

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intraoral trigger point injection by botox

intraoral injection of trigger point of masseter muscle by botulinum toxin

Intervention Type DRUG

transcutaneous trigger point injection by botox

transcutaneous injection of masseter muscle by botulinum toxin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No