- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827122
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
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
- Name: Baraa abdulrahman, BDS
- Phone Number: +966582766220
- Email: Baraa.abdulrahman@riyadh.edu.sa
Study Locations
-
-
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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:
- Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination.
- Aged 20-60 patients.
- Tooth-grinding sounds corroborated by family members or caregivers.
- Cases where bruxism resulted in occlusal surface attrition of posterior teeth
Exclusion Criteria:
- pain in the orofacial region,
- insomnia,
- known botulinum toxin allergy,
- pregnancy,
- neuromuscular disease,
- bleeding disorders,
- antibiotic therapy,
- pulmonary disease that produced coughing during sleep,
- 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:
|
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
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Wake Disorders
- Stomatognathic Diseases
- Parasomnias
- Tooth Diseases
- Bruxism
- Sleep Bruxism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- RC/IRB/2018/1247
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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