Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study

January 31, 2019 updated by: Baraa Abdulrahman, Riyadh Colleges of Dentistry and Pharmacy

Botulinum Toxin A Injectable Solution in the Management of Bruxism

A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. The patients age 18-60 years. According to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

      • Riyadh, Saudi Arabia, 11681
        • Recruiting
        • Riyadh Elm University
        • Contact:
          • Baraa abdulrahman

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination.
  2. Aged 20-60 patients.
  3. Tooth-grinding sounds corroborated by family members or caregivers.
  4. Cases where bruxism resulted in occlusal surface attrition of posterior teeth

Exclusion Criteria:

  1. pain in the orofacial region,
  2. insomnia,
  3. known botulinum toxin allergy,
  4. pregnancy,
  5. neuromuscular disease,
  6. bleeding disorders,
  7. antibiotic therapy,
  8. pulmonary disease that produced coughing during sleep,
  9. infectious skin lesion at the site of the injection.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group one
Botx will be injection in masster muscles 20unit Botx (onabotulinumtoxinA) and visual pain scale will be taken before and after in four intervals 2,8,16,48 weeks
Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.
Other Names:
  • Botox Allergan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction after botox injection subjective
Time Frame: Change in clenching after 2,8,16,48 weeks
Visual pain scale with a score from 0 to 10
Change in clenching after 2,8,16,48 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Baraa abdulrahman, BDS, Riyadh Colleges of Dentistry and Pharmacy

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)

November 13, 2018

Primary Completion (ANTICIPATED)

November 11, 2019

Study Completion (ANTICIPATED)

November 13, 2019

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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