Depigmentation, Gingival Pigmentation, Glutathione, Vitamin C
Conditions
Keywords
depigmentation, vit c, glutathione, gingival depigmentation
Brief 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
Detailed description
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.
Interventions
DRUGVitamin c and glutathione
Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)
PROCEDURESurgical depigmentation
Removal of gingival pigmentation by scalpel
Sponsors
Cairo University
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. group 1 will be treated with conventional scalpel surgical depigmentation 2. group 2 will be treated with non-surgical intra-epidermal injection of vitamin C & glutathione depigmentation. the following clinical measurements will be recorded. 1. The clinical assessment of the degree of gingival pigmentation will be performed using two different indices; * Takashi index * Gingival pigmentation index regular digital photographs which will be taken pre-operative, and post-operatively after 1, 3, 6 and 9 months. 2. Pain and itching will be reported by the patient after the surgical procedure and following each injection visit using visual analogue scale (VAS) at 24 hours 3. Patient satisfaction
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 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." |
| Itching | 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) |
| Patient satisfaction | 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) |
Countries
Egypt
Contacts
CONTACTNourhan A Abdelkhalek
PRINCIPAL_INVESTIGATORNourhan A Abdullah, Phd
Lecturer at faculty of dentistry, Fayoum university
Outcome results
None listed