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Clinical Trials in Egypt / NCT07595705
Recruiting Phase 2

Gingival Hyperpigmentation Treatment

NCT07595705 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Phase 2
Started
2025-08-01
Last updated
2026-05-19

Condition(s) studied

Gingival PigmentationDepigmentationVitamin CGlutathione

Investigational drug(s) / intervention(s)

Vitamin c and glutathioneSurgical depigmentation

Vitamin c and glutathione: Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)

Surgical depigmentation: Removal of gingival pigmentation by scalpel

Study summary

It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005) — baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
    Degree of gingival pigmentation 0: no pigmentation 1. solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units 2. formation of continuous ribbon extending from neighboring solitary units)
  • Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013) — The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.
    Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry Al Fayyum Faiyum Governorate Recruiting

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Other trials for the same condition

Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. Recruiting
Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation Recruiting
Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation Enrolling by invitation
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07595705 on ClinicalTrials.gov ↗ ← All trials in Egypt