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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Botulinum Toxin A Injectable Solution in the Management of Bruxism

Conditions
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Nocturnal Bruxism

Intervention / Treatment
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* Drug: onabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group with bruxism they will be injected in masster muscles bilaterally
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group one<br>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<br>* 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.<br>* Other names: Botox Allergan;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bruxism