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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT04030767
Eligibility Criteria:
Inclusion Criteria:
1. Gummy smile more than 3mm.
2. Adults \>18 years.
3. Non-smokers.
4. Patients with healthy systemic condition
5. Normal clinical crown dimensions.
6. Good oral hygiene.
Exclusion Criteria:
1. Natural dentition upper anterior
2. Pregnant or lactating women.
3. Patients with inflamed gingiva or gingival enlargement.
4. Inflammation or infection at the site of injection.
5. Patients with allergy to botulinum toxin, lactose, and albumin.
6. Concurrent use of aminoglycoside antibiotic that enhances the action of the toxin. (Jaspers, Pijpe, \& Jansma, 2011)
7. \< 3 mm attached gingivae that might create difficulties in flap design, stabilization and suturing.
8. Patients using anticholinesterase or other agents interfering with neuromuscular transmission
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04030767
Study Brief:
Protocol Section:
NCT04030767