Intraoral Injection of Trigger Points by Botox

January 7, 2023 updated by: Shaimaa Mohsen, Fayoum University

Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcutaneous injection
Drug: transcutaneous trigger point injection by botox
transcutaneous injection of masseter muscle by botulinum toxin
Active Comparator: intraoral injection
Drug: intraoral trigger point injection by botox
intraoral injection of trigger point of masseter muscle by botulinum toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 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.
6 weeks post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(OHIP-14) scale
Time Frame: 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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 25, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 7, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC2213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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