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临床试验/CTRI/2025/06/088594
CTRI/2025/06/088594尚未招募1 期

Clinical evaluation of Injectable Platelet rich fibrin and Platelet rich fibrin membrane in Laser assisted gingival depigmentation. - A Randomized Controlled Study

Riddhika kochar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月24日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Healing index

研究概览

简要总结

This study compares two types of platelet concentrates—Injectable Platelet-Rich Fibrin (i-PRF) and Platelet-Rich Fibrin (PRF) membrane—in patients undergoing laser-assisted gingival depigmentation. The aim is to evaluate and compare their effects on wound healing, patient comfort, and tissue regeneration following the procedure. Both biomaterials are derived from the patient’s own blood but differ in their consistency and application method. This comparative analysis will help determine which form of PRF provides better clinical outcomes in terms of healing and aesthetic improvement.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Male and female with age range from 16 to 45 years old.
  • 2.Systemically healthy patients.
  • 3.Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).

排除标准

  • 1.Pregnant and lactating women.
  • 2.Gingival pigmentation associated with occupational hazards.
  • 3.Patients with missing anterior teeth.
  • 4.Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
  • 5.Smokers patients.

结局指标

主要结局

Healing index

时间窗: at 7th day

次要结局

  • Dummett-Gupta Oral Pigmentation Index (DOPI)(baseline, 1 week and 1 month)
  • Gingival biotype(at baseline and after 1 month)
  • Visual Analog Scale (VAS)(at 3rd day and 7th day)

研究者

发起方
Riddhika kochar
申办方类型
Other [self ]

研究点 (1)

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