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Clinical Trials in Egypt / NCT07513727
Recruiting Not applicable

Vitamin C for Gingival Depigmentation

NCT07513727 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-07-29
Last updated
2026-04-07

Condition(s) studied

Gingival HyperpigmentationGingival Melanin Pigmentation

Investigational drug(s) / intervention(s)

Topical Vitamin C ( control Arm) →Vitamin C mesotherapyMicroneedling technique

Topical Vitamin C ( control Arm): Topical application of L-Ascorbic Acid gel (1000 mg in 5 ml distilled water with CMC and PEG), applied once daily on gingival hyperpigmented areas for 1 month.

Vitamin C mesotherapy: vitamin C mesotherapy was administered by delivering intra-mucosal microinjections of L-ascorbic acid into pigmented gingival tissues at the epithelium-connective tissue junction, providing targeted delivery to melanocyte-rich layers. . The treatment will be repeated 3 times with 1 week .

Microneedling technique: Gingival microneedling was performed using a Derma Pen A6 (12-needle row), with penetration depth adjusted to gingival thickness at 700 cycles/min (mode 6). Each gingival side was treated 30-40 seconds per tooth until bleeding points appeared.

Study summary

The purpose of this study is to evaluate the clinical and histopathological efficacy of topical vitamin C applications using three modalities (topical gel, microneedling , and mesotherapy) in gingival depigmentation. Assessment includes clinical evaluation, CIELAB analysis via DOPI, and histopathological examination (Fontana-Masson staining).

Eligibility

Sex
ALL
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: \- 1- Both genders aged from 20-35 years. 2- Patients clinically diagnosed with physiologic gingival melanin pigmentation in the maxillary and mandibular keratinized gingiva. 3- Patients complaining of compromised esthetics. 4- Patients should be systemically free any disease as verified by a medical history diagnostic sheet or via health questionnaire Exclusion Criteria: \- 1- Patient clinically diagnosed with periodontitis and / or manifest poor oral hygiene with high plaque and gingival indices 2- Pregnant or lactating females. 3- Patients with clinical diagnosed lesion in the area of interest primarily the gingivae encompassing the maxillary /mandibular anterior teeth e.g. pigmented lesion of intestinal polyposis syndrome, McCune-Albright syndrome and fibro-osseous lesions as florid osseous dysplasia. 4- Patient with previous treatment of gingival hyperpigmentation. 5- Patients with history of being allergic to the vitamin C. 6- Patients with any systemic disease ( e.g. Addison disease ) or drugs consumed that may cause clinical gingival hyperpigmentation 7- Patients who are active or previous smokers.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Al-Azhar University Faculty of Dentistry ( Girls ) Cairo Cario Governorate Recruiting

More Al-Azhar University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07513727 on ClinicalTrials.gov ↗ ← All trials in Egypt