Status:
NOT_YET_RECRUITING
Evaluation of BTX Injections in Treatment of Bruxism
Lead Sponsor:
Alexandria University
Conditions:
Bruxism
Eligibility:
All Genders
20-60 years
Phase:
PHASE3
Brief 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 irr...
Detailed Description
Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw clenching and/or tooth grinding. It was suggested in international consensus conference that bruxism should have t...
Eligibility Criteria
Inclusion
- Patient between 20 and 60 years of age.
- Pain related to the masseter muscles and TMJ area due to bruxism.
- Patient who has never received botulinum toxins.
- Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).
Exclusion
- Pregnant or breastfeeding women.
- Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
- Patients with epilepsy or a previous seizure episode.
- Injection site infection (masseter or temporalis).
- Hypersensitivity or allergy to botulinum toxin or any of its excipients.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05980559
Start Date
January 15 2024
End Date
April 15 2024
Last Update
January 5 2024
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