Evaluation of BTX Injections in Treatment of Bruxism

• Status: Not yet recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.

The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

1. Patient between 20 and 60 years of age.

2. Pain related to the masseter muscles and TMJ area due to bruxism.

3. Patient who has never received botulinum toxins.

4. Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).

Exclusion Criteria:

1. Pregnant or breastfeeding women.

2. Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.

3. Patients with epilepsy or a previous seizure episode.

4. Injection site infection (masseter or temporalis).

5. Hypersensitivity or allergy to botulinum toxin or any of its excipients.