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

Phase 2

• Conditions: Nocturnal Bruxism
• Interventions: Drug: onabotulinumtoxinA

• Registration Number: NCT03827122
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-11-13
• Status Verified: 2019-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group one	onabotulinumtoxinA	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

Primary Outcome Measures

Name	Time	Method
Pain reduction after botox injection subjective	Change in clenching after 2,8,16,48 weeks	Visual pain scale with a score from 0 to 10

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia