Gingival Hyperpigmentation Treatment

Phase 2RecruitingNCT07595705

Cairo University30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gingival Pigmentation Depigmentation Vitamin C Glutathione

Interventions

Vitamin c and glutathioneDRUG

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

Surgical depigmentationPROCEDURE

Removal of gingival pigmentation by scalpel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry

Al Fayyum, Faiyum Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

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)

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

Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)

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

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.

Secondary Outcomes

Pain score

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."

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

Itching

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)

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

Patient satisfaction

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)

Central Contacts

Nourhan A Abdelkhalek

CONTACT

01005802478 naa14@fayoum.edu.eg

Data from ClinicalTrials.gov

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