Faculty of Dentistry
Al Fayyum, Faiyum Governorate, 63511, Egypt
Location status: Recruiting
Location contact
Amr E Emaraa, Associate professor
CONTACT
NCT Number: NCT07595705
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Al Fayyum, Faiyum Governorate, 63511, Egypt
Location status: Recruiting
Amr E Emaraa, Associate professor
CONTACT
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.
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:
Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:
Exclusion criteria
Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)
Removal of gingival pigmentation by scalpel
Time frame: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
Degree of gingival pigmentation 0: no 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.
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: 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."
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)
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)
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
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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.
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