Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT05980559
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT05980559
Study Brief:
Protocol Section:
NCT05980559