RecruitingPhase 4NCT06312605

The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial)

Patient Response and Recurrence Rate Following Adjunctive Intra-Mucosal or Topical Ascorbic Acid To Gingival Depigmentation Using Surgical Scalpel Technique: (Randomized Clinical and Histological Trial)


Sponsor

Ain Shams University

Enrollment

24 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question\[s\] it aims to answer are: * Pigment recurrence after one year. * Patient satisfaction and histological response of tissues. Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen. Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vitamin C supplements can help prevent the return of dark gum pigmentation after a gum-lightening procedure. Researchers want to see if adding vitamin C to standard care reduces how quickly natural gum darkening comes back. **You may be eligible if...** - You are between 18 and 40 years old (any gender) - You are generally healthy with no chronic medical conditions - You have natural dark pigmentation on your gums (upper or lower) rated moderate to severe on a standard scale - Your gum tissue is relatively thick (1.5 mm or more) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are a smoker (cigarettes, cigars, or water pipe) - You take medications known to affect gum color (such as chloroquine, minocycline, or ketoconazole) - You already take vitamin C supplements for any reason - You have a known allergy to vitamin C or its derivatives - You have been diagnosed with periodontitis (gum disease with deep pockets or bone loss) - You have poor oral hygiene or ongoing gum inflammation after initial treatment Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREInjectable applied vitamin C

Surgical gingival depigmentation is done for all participants, after then they receive injectable vitamin C

PROCEDURETopical applied Vitamin C

Surgical gingival depigmentation is done for all participants, after then they are instructed to apply topical vitamin C

PROCEDURESurgical depigmentation only

Surgical gingival depigmentation only without any drug


Locations(1)

Faculty AinShams University

Cairo, Egypt

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NCT06312605


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