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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06075134
Eligibility Criteria:
Inclusion Criteria:
* Patients with excessive gingival display.
* Patients with esthetic concerns.
* Patients with mild to moderate VME (vertical maxillary excess).
* Normal clinical crown dimensions.
* Patients aged 18 to 50.
* Systemically healthy patients.
* Non-smokers.
Exclusion Criteria:
* Patients with severe VME (vertical maxillary excess).
* Pregnant and breastfeeding women.
* Patients with gingival inflammation and/or enlargement.
* Inflammation or infection at the site of injection.
* Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
* Patients using anticholinesterase or other agents affecting neuromuscular transmission.
* Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
* Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06075134
Study Brief:
Protocol Section:
NCT06075134