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
SAI PRIYA
Army College Of Dental Sciences
研究点 (1)
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