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临床试验/CTRI/2025/06/088632
CTRI/2025/06/088632尚未招募不适用

Comparative evaluation of microneedling technique and diode laser in gingival depigmentation: A prospective randomized study

Dr Natasha Singh Postgraduate student1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Recurrence of pigmentation in

研究概览

简要总结

Subjects with periodontally healthy status with physiological melanin gingival pigmentation (DOPI Index ≤ 1) with phenotype (2mm) will be selected and they undergo a depigmentation procedure either through microneedling or diode laser technique. The vas pain scale will be measured at 24 hours and 1 week. Recurrence of pigmentation will be assessed at 3, 6 ,12 months. in the subjects treated with Microneedling and Diode laser technique..

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Group 1 Microneedling 1 Periodontally healthy patient between 18 and 40 years 2 Patients with physiological melanin gingival pigmentation DOPI Index less than l 3 Patient with phenotype 2mm.
  • 4Patient willing to maintain regular appointments and having good compliance Group 2 Diode laser 1.Periodontally healthy patient between 18 and 40 years 2 Patients with physiological melanin gingival pigmentation DOPI Index less than 1 3 Patient with phenotype 2mm 4 Patient willing to maintain regular appointments and having good compliance.

排除标准

  • 1 Systemically compromised patients or any medication that influence melanin pigmentation 2 Pregnant or lactating women 3 Smokers or tobacco chewers 4 Subjects undergone periodontal therapy in last 3 month
  • Subjects with Vitiligo.

结局指标

主要结局

Recurrence of pigmentation in

时间窗: At 3 months, 6 months and 12 months.

depigmentation when treated by

时间窗: At 3 months, 6 months and 12 months.

microneedling and diode laser.

时间窗: At 3 months, 6 months and 12 months.

次要结局

  • evaluation of pain using VAS scale(24 hours and 7 days)

研究者

发起方
Dr Natasha Singh Postgraduate student
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Natasha Singh

Manav Rachna International institute of Research and Studies

研究点 (1)

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