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

Riyadh Colleges of Dentistry and Pharmacy20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nocturnal Bruxism

Interventions

onabotulinumtoxinADRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Riyadh Elm University

Riyadh, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

Pain reduction after botox injection subjective

Visual pain scale with a score from 0 to 10

Time frame: Change in clenching after 2,8,16,48 weeks

Central Contacts

Baraa abdulrahman, BDS

CONTACT

+966582766220 Baraa.abdulrahman@riyadh.edu.sa

Data from ClinicalTrials.gov

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