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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07402720
Eligibility Criteria:
Inclusion Criteria:
* Presence of melanin hyperpigmentation (Dummett Oral Pigmentation Index ≥ 2)
* Presence of bilateral gingival pigmentation extending at least 3 teeth in each arch
* Age range: e.g., 18-40 years (adjust based on your sample)
* Non-smokers (or smokers \<10 cigarettes/day, specify if allowed)
* Systemically healthy
* Willingness to participate and sign informed consent 8
* Available for follow-up appointments
* No previous periodontal surgery in the area other than prophylaxis
Exclusion Criteria:
* • Systemic conditions affecting healing (e.g., diabetes mellitus,immunosuppressive disorders)
* Pregnant or lactating women
* Heavy Smokers
* Ongoing orthodontic treatment in the affected area
* Use of medications affecting gingiva (e.g., phenytoin, cyclosporine, calcium channel blockers)
* Poor oral hygiene at baseline
* Active periodontal pockets \>3 mm or clinical attachment loss
* Allergy to local anesthetics or materials used in the procedure
* History of alcohol or drug abuse
* Psychological conditions that may interfere with compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07402720
Study Brief:
Protocol Section:
NCT07402720