Gingival Depigmentation with Vitamin C and Glutathione vs. Surgical Depigmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 trial compares two approaches to gingival depigmentation: injections of vitamin C and glutathione and traditional surgical depigmentation. Eligible participants are adults with gingival pigmentation scores of 1–3 who are otherwise healthy and committed to oral hygiene. The study aims to see if the chemical treatment can achieve similar cosmetic results to scalpel removal while potentially reducing invasiveness. Outcomes likely include cosmetic appearance, safety, and patient satisfaction. The trial is conducted at Cairo University with Fayoum University as a collaborator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:

1. Score0:absence of pigmentation
2. Score1:spotsofbrowntoblackcolororpigments
3. Score2:browntoblackpatchesbutnotdiffusepigmentation
4. Score3:diffuse brown to black pigmentation,marginal,and attached.

Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:

1. above 18yrs
2. systemically free
3. physiologic gingival hyperpigmentation related to esthetic region
4. well maintained oral hygiene and willing to undergo minor surgical procedures

Exclusion Criteria:

1. systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
2. pregnant and lactating mothers
3. usage of chlorhexidine or povidone iodine
4. Local causes (smoking)
5. periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
6. non compliant patients

Where it's running

• Faculty of Dentistry
  Al Fayyum, Faiyum Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Nourhan A Abdullah, Phd — Lecturer at faculty of dentistry, Fayoum university
• Study coordinator: Nourhan A Abdelkhalek
• Email: naa14@fayoum.edu.eg
• Phone: 01005802478

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.