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临床试验/NCT07595705
NCT07595705招募中2 期

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

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
30
试验地点
1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Abdallah Abdelkhalek

Doctor

Cairo University

研究点 (1)

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