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临床试验/CTRI/2021/11/037987
CTRI/2021/11/037987已完成2 期

COMPARATIVE EVALUATION OF PDGF-BB LEVELS IN PATIENTS WITH ISOLATED GINGIVAL RECESSION TREATED BY GINGIVAL PEDICLE SPLIT THICKNESS TUNNEL TECHNIQUE WITH AND WITHOUT USING I-PRF:A RANDOMIZEDCONTROLLED TRIAL.

LEENA PATIL1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月27日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
To clinically evaluate and compare clinical parameters in Gingival pedicle split thickness tunnel technique AND deepithelialized gingival graft along with and without using I PRF for the treatment of isolated gingival recession

研究概览

简要总结

Gingivalrecession is defined as the apical shift of the gingival margin with respect tothe cemento-enamel junction (CEJ), which leads to the exposure of the rootsurface. In this comparative study, 20 patients of isolated gingival recession willbe selected randomly based on miller’s classification of gingival recession, 10in each group.Each subject will begiven a detailed verbal and written description of the study. Initialpreparation of the recipient site will include a thorough scaling and root planing. Afteradministration of local anaesthesia Gingival Pedicle Split Thickness (GPST)technique begins. Deepithelialized free gingival graft will be harvested fromthe palate according to the recipient bed measurements. For the preparation ofI-PRF, 10ml of blood will be drawn and centrifuged at 700 rpm for 3 minutes 13,harvested de-epithelialized free gingival graft will be coated with I-PRF, andthen it will be inserted onto the prepared site and sutured. In the control group, the same procedure will be performed without using I-PRF. Clinical parameters willbe evaluated after 4 months. Comparison of biochemical and clinical findingswill lead to conclusive points.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Isolated Gingival recession defects are classified as either Miller’s Class I or II defects.
  • Subjects who are systemically healthy.

排除标准

  • Patients with systemic problems.
  • Patients who are smokers and tobacco users.
  • Pregnant and Lactating mothers.

结局指标

主要结局

To clinically evaluate and compare clinical parameters in Gingival pedicle split thickness tunnel technique AND deepithelialized gingival graft along with and without using I PRF for the treatment of isolated gingival recession

时间窗: change in clinical parameter was calculated at 4 months from baseline

次要结局

  • To biochemically evaluate the PDGF BB levels in Gingival pedicle split thickness tunnel technique and deepithelialized gingival graft along with and without using I PRF for the treatment of isolated gingival recession(change in clinical parameter was calculated at 4 months from baseline)

研究者

发起方
LEENA PATIL
申办方类型
Other [self]

研究点 (1)

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