Vitamin C for Gingival Depigmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Vitamin C ( control Arm), Vitamin C mesotherapy, Microneedling technique.
- Who it may be relevant to
- Registry conditions: Gingival Hyperpigmentation, Gingival Melanin Pigmentation. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Histological Evaluation of Topical Vitamin C Application Using Three Modalities in Gingival Depigmentation
Overview
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).
Interventions
- Drug 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. - Procedure 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 . - Procedure 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.
Primary outcome measures
- Dummet oral Pigmentation Index (DOPI). [Time frame: baseline to 3 months]
Secondary outcome measures (2)
- Melanin area fraction [Time frame: baseline to 3 months]
- Patient satisfaction [Time frame: 2 weeks , 1 month , and 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Al-Azhar University Faculty of Dentistry ( Girls ) — Cairo
Identifiers
NCT: NCT07513727 · K.Al.K-2025-01 · OMPDR-105-1t