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Intraoral Injection of Trigger Points by Botox

Primary Purpose

Myofacial Pain

Status
Enrolling by invitation
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
intraoral trigger point injection by botox
transcutaneous trigger point injection by botox
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofacial Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fayoum University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transcutaneous injection

intraoral injection

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

(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

Full Information

First Posted
January 4, 2023
Last Updated
January 7, 2023
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05673655
Brief Title
Intraoral Injection of Trigger Points by Botox
Official Title
Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 25, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcutaneous injection
Arm Type
Active Comparator
Arm Title
intraoral injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
intraoral trigger point injection by botox
Intervention Description
intraoral injection of trigger point of masseter muscle by botulinum toxin
Intervention Type
Drug
Intervention Name(s)
transcutaneous trigger point injection by botox
Intervention Description
transcutaneous injection of masseter muscle by botulinum toxin
Primary Outcome Measure Information:
Title
pain score
Description
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 Outcome Measure Information:
Title
(OHIP-14) scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fayoum University
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

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Intraoral Injection of Trigger Points by Botox

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