Health TrialsbyHealthPanel

Vitamin C for Gingival Depigmentation

ConditionsGingival HyperpigmentationGingival Melanin Pigmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorAl-Azhar University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Topical Vitamin CActive comparator 3 interventions
Group B: microneedling with topical Vitamin C gelExperimental treatment 3 interventions
Group C: Vitamin C MesotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline to 3 months

Secondary outcomes

1

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.

Time frame
baseline to 3 months
2

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

Time frame
2 weeks , 1 month , and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov
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