Back to resultsBotulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
Primary Purpose
Nocturnal Bruxism
Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
onabotulinumtoxinA
Sponsored by
About this trial
This is an interventional treatment trial for Nocturnal Bruxism focused on measuring Bruxism
Eligibility Criteria
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.
Sites / Locations
- Riyadh Elm UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group one
Arm Description
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
Outcomes
Primary Outcome Measures
Pain reduction after botox injection subjective
Visual pain scale with a score from 0 to 10
Secondary Outcome Measures
Full Information
NCT ID
NCT03827122
First Posted
January 11, 2019
Last Updated
January 31, 2019
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT03827122
Brief Title
Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
Official Title
Botulinum Toxin A Injectable Solution in the Management of Bruxism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
November 11, 2019 (Anticipated)
Study Completion Date
November 13, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Bruxism
Keywords
Bruxism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single group with bruxism they will be injected in masster muscles bilaterally
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group one
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
Botox Allergan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain reduction after botox injection subjective
Description
Visual pain scale with a score from 0 to 10
Time Frame
Change in clenching after 2,8,16,48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baraa abdulrahman, BDS
Phone
+966582766220
Email
Baraa.abdulrahman@riyadh.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baraa abdulrahman, BDS
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh Elm University
City
Riyadh
ZIP/Postal Code
11681
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baraa abdulrahman
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
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