跳至主要内容
临床试验/CTRI/2025/04/084025
CTRI/2025/04/084025尚未招募2 期

Revolutionizing Gingival Depigmentation: Unveiling the Efficacy of Microneedling and Scalpel Technique with and without Topical Vitamin C – A Split-Mouth Clinical Trial.

SAI PRIYA1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Reduction of pigmentation - can be accessed using Dummett oral pigmentation index and Hedin melanin index

研究概览

简要总结

This study aims to compare the effects of four different treatment modalities for gingival pigmentation, using a split-mouth design where each patient’s four quadrants are assigned to distinct treatment groups:

  • Group A: Microneedling with Vitamin C
  • Group B: Scalpel with Vitamin C
  • Group C: Scalpel alone
  • Group D: Microneedling alone

Patients are advised to avoid acidic or hot beverages for 24 hours post-treatment.

  • 24 Hours Post-Treatment: Visual Analog Scale (VAS) for pain and verbal scale for wound itching are recorded.
  • 1 Week: Periodontal dressing is removed, and DOPI and HMI are re-recorded.
  • 1 Month & 3 Months: Follow-up visits are scheduled to assess and record DOPI and HMI scores.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • With anterior melanin pigmentation ranging from mild to severe based on Dummets oral pigmentation index.

排除标准

  • Fully edentulous individuals.
  • Pregnant and lactating women.
  • Smokers, Patients who are under medications which affect the gingival color.
  • Patients having any systemic condition that might induce or affect the melanin pigmentation.

结局指标

主要结局

Reduction of pigmentation - can be accessed using Dummett oral pigmentation index and Hedin melanin index

时间窗: At baseline, 1 week, 3 months and 6 months

次要结局

  • Patient pain and wound itching scores by Visual analogue scale (VAS) and Verbal scale for wound itching respectively

研究者

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

SAI PRIYA

Army College Of Dental Sciences

研究点 (1)

Loading locations...

相似试验