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

• Status: Unknown status
• Trial end date: 2019-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

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.