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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

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.

Condition or disease Intervention/treatment Phase
Nocturnal Bruxism Drug: onabotulinumtoxinA Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Botulinum Toxin A Injectable Solution in the Management of Bruxism
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : November 11, 2019
Estimated Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827122


Contacts
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Contact: Baraa abdulrahman, BDS +966582766220 Baraa.abdulrahman@riyadh.edu.sa

Locations
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Saudi Arabia
Riyadh Elm University Recruiting
Riyadh, Saudi Arabia, 11681
Contact: Baraa abdulrahman         
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Principal Investigator: Baraa abdulrahman, BDS Riyadh Colleges of Dentistry and Pharmacy

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Responsible Party: Baraa Abdulrahman, Master Resident in Oral Diagnostics, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03827122     History of Changes
Other Study ID Numbers: RC/IRB/2018/1247
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Baraa Abdulrahman, Riyadh Colleges of Dentistry and Pharmacy:
Bruxism
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents