Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07595705

Gingival Hyperpigmentation Treatment

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry

Al Fayyum, Faiyum Governorate, 63511, Egypt

Location status: Recruiting

Location contact

Amr E Emaraa, Associate professor

CONTACT

About this study

Over the last decade, an increasing interest has been observed in esthetic treatments. In fact, The smile is an important aesthetic component of the face and significantly impacts the perception of beauty and psychological well-being. Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.

Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected". Moreover, it can be attributed to multiple external or internal factors. It may be physiological (excessive melanin deposition) or pathological (smoking).

Gingival Depigmentation can be treated by different modalities including chemical and surgical methods. Lately, gingival Depigmentation was carried out by lasers, cryosurgery and radiosurgery.

Additionally, multiple evidence have suggested the use of ascorbic acid (vitamin C) to treat gin- gival pigmentation. It was demonstrated that ascorbic acid is a water-soluble antioxidant and an essential nutrient for collagen biosynthesis. Furthermore, it was proven that it is effective in the elimination of hyperpigmented lesion.

Lately, glutathione has come into focus in aesthetics because of its antimelanogenic (inhibits melanosome transfer from melanocytes to keratinocytes) and antioxidant properties. It aids in skin lightening because it inhibits tyrosinase enzymes. Moreover, the use of vitamin C and glutathione has been well established, as they participate in antioxidant cellular defense systems. The series of oxidation-reduction reactions that allow vitamin C and glutathione to interact each other makes them unique The aim of the current study is to evaluate the efficacy of its rather-epidermal vitamin C in conjunction with glutathione injection compared to the conventional surgical technique in order to manage patients with gingival hyperpigmentation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Score0:absence of pigmentation
  • Score1:spotsofbrowntoblackcolororpigments
  • Score2:browntoblackpatchesbutnotdiffusepigmentation
  • 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:

  • above 18yrs
  • systemically free
  • physiologic gingival hyperpigmentation related to esthetic region
  • well maintained oral hygiene and willing to undergo minor surgical procedures

Exclusion criteria

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

Treatment and study plan

Vitamin c and glutathione

Drug

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

Surgical depigmentation

Procedure

Removal of gingival pigmentation by scalpel

Primary outcomes

  1. Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)

    Time frame: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month

    Degree of gingival pigmentation 0: no pigmentation

    • solitary unit (s) of pigmentation in papillary gingiva without extension between neighboring solitary units
    • formation of continuous ribbon extending from neighboring solitary units)
  2. Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)

    Time frame: 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

Secondary outcomes

  1. Pain score

    Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)

    VAS scores pain will be divided into ten numerical parts consisting of one cm each on a horizontal line with two endpoints (left and right), with "0" representing "no pain" to "10" representing "severe pain."

  2. Itching

    Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)

    A vertical scale for wound itching was measured with a scale with five scores: no itching (0) mild itching (1point) moderate itching (2 points) severe itching (3 points) extremely severe (4 points)

  3. Patient satisfaction

    Time frame: At the end of the follow up period ( 9 months)

    using a 5- graded self-assessment analysis (Huh et al. 2003). excellent (grade 4: improved over 75%) good (grade 3: improved 50e75%) moderate (grade 2: improved 25e50%) fair (grade 1: improved less than 25%) no change or worse (grade 0: not improved or darkened)

Study contacts

Contact information is provided by the study sponsor or research team.

Nourhan A Abdelkhalek

CONTACT

[email protected]

01005802478

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Fayoum University

Registry information

Official study title

Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.