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NCT Number: NCT07513727

Vitamin C for Gingival Depigmentation

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).

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Key information

Conditions

Gingival Hyperpigmentation Gingival Melanin Pigmentation

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University Faculty of Dentistry ( Girls )

Cairo, Cario Governorate, 11651, Egypt

Location status: Recruiting

Location contact

khawlah Q alkhalidi, BDS, MSc

CONTACT

[email protected]

00201556811594

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Vitamin C ( control Arm)

Drug

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

Procedure

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

Procedure

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 outcomes

  1. Dummet oral Pigmentation Index (DOPI).

    Time frame: baseline to 3 months

    Evaluating the degree of melanin pigmentation at baseline and follow-up visits. Scoring was conducted by calibrated examiners under standardized lighting conditions to ensure reproducibility of clinical measurements.

Secondary outcomes

  1. Melanin area fraction

    Time frame: baseline to 3 months

    Quantitative assessment of gingival melanin pigmentation was performed by histopathological analysis of gingival tissue specimens stained with Fontana-Masson, and the mean melanin-containing area fraction was calculated at baseline and follow-up to evaluate pigmentation changes according to established morphometric methods used in clinical histopathological studies.

  2. Patient satisfaction

    Time frame: 2 weeks , 1 month , and 3 months

    To score degree of pain experienced during and after treatment and the degree of patient satisfaction with the cosmetic result of the procedure was used.2 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

khawlah Q al-khalidi, BDS, MSc

CONTACT

[email protected]

00201556811594

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Clinical and Histological Evaluation of Topical Vitamin C Application Using Three Modalities in Gingival Depigmentation

Acronym: VitC-DePg

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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