跳至主要内容
临床试验/CTRI/2025/02/080441
CTRI/2025/02/080441尚未招募4 期

Gingival depigmentation using Microneedling technique with and without topical application of Niacinamide versus the conventional scalpel technique: A randomized controlled clinical trail

Sanjyoti Patil1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
The effect of using the MN technique along with and without topical application of niacinamide compared to the effect of conventional scalpel technique in reducing pigmentation in hyperpigmented gingiva.

研究概览

简要总结

Gingival depigmentation is a periodontal plastic procedure aimed at the removal of melanocytic pigmentation, utilizing various methods such as surgical scraping and electrosurgery. Among these options, the microneedling (MN) technique has emerged as a minimally invasive approach that enhances collagen regeneration through the creation of micro-perforations in the tissue, facilitating improved penetration of topically applied therapeutic agents.

Niacinamide, an amide derivative of vitamin B3, is recognized for its skin-lightening properties, particularly in the context of treating cutaneous pigmentation. Its mechanism of action involves the suppression of melanosome transfer from melanocytes to keratinocytes, thereby reducing pigmentation.

While numerous clinical investigations have evaluated the efficacy of the MN technique for pigmentation treatment and skin rejuvenation, there is a notable paucity of dental studies addressing its effects within the oral cavity. In light of this gap in the literature, the present study employs the MN technique for the treatment of gingival pigmentation in conjunction with the topical application of niacinamide as a depigmenting agent. This dual approach aims to assess the potential benefits of combining these methodologies in the context of oral pigmentation management.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Individuals with physiologic melanin pigmentation on the anterior portion of the upper and lower gingiva.
  • Systemically healthy individuals.
  • Individuals of 16-45 years of age from both genders.

排除标准

  • Patients with habits of tobacco in any form, pan chewing etc.
  • Pregnant or lactating women.
  • Individuals with periodontal disease.
  • Patients who had previous depigmentation procedures done.
  • Patients who are allergic to niacinamide.
  • Patients on drugs that cause gingival pigmentation like antimalarial, oral contraceptives, ketoconazole etc.

结局指标

主要结局

The effect of using the MN technique along with and without topical application of niacinamide compared to the effect of conventional scalpel technique in reducing pigmentation in hyperpigmented gingiva.

时间窗: 4 months

次要结局

  • Whether microneedling technique with and(without topical niacinamide shows better post)
  • Whether microneedling technique with and(without topical niacinamide shows less post)

研究者

发起方
Sanjyoti Patil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanjyoti Patil

Tatyasaheb Kore Dental College and Research Center, New Pargaon

研究点 (1)

Loading locations...

相似试验