Gingival Hyperpigmentation Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin c and glutathione, Surgical depigmentation.
- Who it may be relevant to
- Registry conditions: Gingival Pigmentation, Depigmentation, Vitamin C, Glutathione. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
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
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
- Drug Vitamin c and glutathione
Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening) - Procedure Surgical depigmentation
Removal of gingival pigmentation by scalpel
Primary outcome measures
- 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 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.]
Secondary outcome measures (3)
- Pain score [Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)]
- Itching [Time frame: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)]
- Patient satisfaction [Time frame: At the end of the follow up period ( 9 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry — Al Fayyum
Identifiers
NCT: NCT07595705 · IRB00012891#159