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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT06674733
Eligibility Criteria:
Inclusion Criteria:
1. Self-reported teeth clenching or grinding
2. Tenderness or fatigue in the masticatory muscles upon palpation
3. Increased morning muscle pain
4. Localized myofascial pain in the jaw, face, or neck region
5. Irregular or excessive enamel wear consistent with bruxism
6. Grinding sounds during sleep confirmed by a partner
7. Morning jaw muscle stiffness and spasms causing sleep disturbances
8. Individuals older than 18 years,
9. Individuals younger than 60 years,
10. Provided informed voluntary consent
Exclusion Criteria:
1. Botulinum toxin injection into the masseter muscle within the last 6 months
2. Use of night guards
3. Pathology or history of surgery involving the masseter muscle or parotid gland
4. Benign or malignant tumors in the mandibular region
5. History of alcohol or substance abuse
6. Age below 18 or above 60
7. Pregnancy, postpartum period, or breastfeeding
8. Infection or dermatological lesions at the injection site
9. Diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
10. Known allergy or skin reaction to botulinum toxin A or essential oils used in aromatherapy
11. Use of muscle relaxants or other medications that may affect muscle function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06674733
Study Brief:
Protocol Section:
NCT06674733