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

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ClinicalTrials.gov Identifier: NCT03827122
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Baraa Abdulrahman, Riyadh Colleges of Dentistry and Pharmacy

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
Official Title  ICMJE Botulinum Toxin A Injectable Solution in the Management of Bruxism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single group with bruxism they will be injected in masster muscles bilaterally
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nocturnal Bruxism
Intervention  ICMJE Drug: onabotulinumtoxinA
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 Name: Botox Allergan
Study Arms  ICMJE 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
Intervention: Drug: onabotulinumtoxinA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 13, 2019
Estimated Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Baraa abdulrahman, BDS +966582766220 Baraa.abdulrahman@riyadh.edu.sa
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827122
Other Study ID Numbers  ICMJE RC/IRB/2018/1247
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Baraa Abdulrahman, Riyadh Colleges of Dentistry and Pharmacy
Study Sponsor  ICMJE Riyadh Colleges of Dentistry and Pharmacy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Baraa abdulrahman, BDS Riyadh Colleges of Dentistry and Pharmacy
PRS Account Riyadh Colleges of Dentistry and Pharmacy
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP