跳至主要内容
临床试验/CTRI/2024/07/070297
CTRI/2024/07/070297尚未招募3 期

Evaluation of gingival depigmentation using microneedling procedure with vitamin-c and electrosurgery: A split mouth randomized controlled trial.

Dr Souparnika M Kulkarni1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
To compare the efficiency of microneedling procedure with vitamin-c and electrosurgery for

研究概览

简要总结

The gingiva is a part of oral mucosa that covers the alveolar process of the jaws and surrounds the neck of the tooth.The color of healthy gingiva is coral pink. Gingival color changes due to the degree of keratinization ,vascularity, gingival epithelial thickness and pigmentation. Gingival pigmentation is maybe due to physiological or pathological factor which causes increased formation of melanin granules in melanocytes. Other causes for hyperpigmentation are genetics, drugs, and metals like bismuth, arsenic, mercury and lead. Lead pigmentation is due to perivascular precipitation of metallic sulfides in subepithelial connective tissue, endocrine disorders like Peutz-Jeghers syndrome and habits (smoking).Gingival pigmentation is more commonly seen in females than males. Dark skinned individuals will be having more melanin production in their body. Gingival depigmentation is a periodontal plastic procedure where removal of the epithelium layer along with connective tissue so that new gingival epithelium regenerates. Treatment options for gingival hyperpigmentation may be divided into two groups: techniques to eliminate the pigments and hide the pigments. Pigment elimination can be done surgically, non-surgically, or chemically. Scalpel surgery, laser ablation, cryosurgery, bur abrasion electrocautery, and radiosurgery are some of the most common surgical techniques. Chemical cauterization is the most common non-surgical method. Use of free gingival autograft operations and the acellular dermal matrix allograft are examples of masking gingival colors. Microneedling a novel non surgical procedure that necessitates puncturing the skin with sterilized microneedles on a regular basis. The needles pierce the skin and generate very tiny pores known as micro-conduits, these micro-injuries cause minor surface bleeding and initiation of a wound-healing pathway that includes inflammation, proliferation, and remodeling. Vitamin C is a water-soluble antioxidant referred to as ascorbic acid, is vital to the growth of strong bones, teeth, gums, ligaments, and blood vessels and is involved in important functions.Also, the anti-pigmentation properties of vitamin C are evident. It interacts with copper and inhibits the tyrosinase enzyme’s action, thus decreasing melanin formation. There are many articles providing various comparative studies with electrosurgery, but the comparison of different techniques with microneedling has not been done as per our knowledge. The rationale behind the study is to compare the efficacy of microneedling procedure with vitamin-c and electrosurgery for treating gingival pigmentation.

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients with age group between 18-50 years with no previous treatment that affect the gingival health or color.
  • Subjects with mild to severe gingival pigmentation.
  • (DOPI: Dummet and oral pigmentation index).
  • Subjects with good oral hygiene.

排除标准

  • Tobacco chewers and smokers.
  • Fully edentulous patients.
  • Patients who have any underlying systemic disease that induces the production of melanin.
  • Pregnant and lactating women.
  • Patient who are taking medications that influence the gingival color such as minocycline, zidovudine Patients allergic to vitamin-c.

结局指标

主要结局

To compare the efficiency of microneedling procedure with vitamin-c and electrosurgery for

时间窗: 6month

treating gingival pigmentation.

时间窗: 6month

次要结局

  • To evaluate the intensity & extension of pigmentation, bleeding, wound healing, post-operative(pain & recurrence following gingival depigmentation using microneedling procedure with)

研究者

发起方
Dr Souparnika M Kulkarni
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Souparnika M Kulkarni

KVG Dental College and Hospital

研究点 (1)

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