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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03252418
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients with age ranging from 18 years old to 40 years old.
* Bilaterally symmetric gingival hyperpigmentation on the maxillary and mandibular labial keratinized gingiva between canines.
* Patients free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
* Patients with thick gingival biotype ≥ 3 mm.
Exclusion Criteria:
* Presence of local condition that may cause gingival hyperpigmentation (traumatized epithelium caused by defective fixed prosthesis or restoration).
* Smokers.
* Pregnant or lactating females.
* Patients with poor oral hygiene, incompliance to treatment and persistence gingival inflammation after phase I periodontal therapy.
* Clinically diagnosed periodontitis (attachment and bone loss, presence of periodontal pockets, gingival recession and tooth mobility).
* Previous treatment to pigmentation.
* Patients taking supplementary vitamin C for any reason.
* Known sensitivity to ascorbic acid or any of its derivatives.
* Patients taking any drug that may cause gingival pigmentation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03252418
Study Brief:
Protocol Section:
NCT03252418