Vitamin C for Gingival Depigmentation (VitC-DePg)

Clinical and Histological Evaluation of Topical Vitamin C Application Using Three Modalities in 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).

Study Overview

• Status: Recruiting
• Conditions: Gingival Hyperpigmentation; Gingival Melanin Pigmentation
• Intervention / Treatment: Drug: Topical Vitamin C ( control Arm); Procedure: Vitamin C mesotherapy; Procedure: Microneedling technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: khawlah Q al-khalidi, BDS, MSc; Phone Number: 00201556811594; Email: khawlahalkhalidi555@gmail.com

Study Locations

• Egypt
  • Cario Governorate
    • Cairo, Cario Governorate, Egypt, 11651
      • Recruiting
      • Al-Azhar University Faculty of Dentistry ( Girls )
      • Contact: khawlah Q alkhalidi, BDS, MSc; Phone Number: 00201556811594; Email: khawlahalkhalidi555@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical Vitamin C; Patients will be instructed to apply ( L- Ascorbic acid 1000 mg) containing gel in 5 ml distilled water, Polyethylene Glyco (PEG), Potassium Sorbate, in addition to Sodium Carboxymethyl Cellulose (CMC)] and Carbomer once daily for 1 months	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.
Experimental: microneedling with topical Vitamin C gel; Microneedling was performed on the gingival tissue using a dermal pin device until the appearance of pinpoint bleeding, indicating adequate micro-injury to stimulate tissue remodeling. The treated area was subsequently irrigated with normal saline and gently dried with sterile gauze. This procedure was repeated after a two-week interval to enhance the clinical effect.	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.
Experimental: 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 .	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dummet oral Pigmentation Index (DOPI).	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.	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melanin area fraction	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.	baseline to 3 months
Patient satisfaction	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	2 weeks , 1 month , and 3 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Ascorbic Acid
• Other Study ID Numbers: K.Al.K-2025-01; OMPDR-105-1t (Other Identifier: Al- Azhar University -Faculty of Dentistry Department of Oral Medicine, Periodontology, Oral Diagnosis and Dental Radio)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No