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临床试验/CTRI/2025/02/080320
CTRI/2025/02/080320尚未招募4 期

A COMPARATIVE EVALUATION OF GUM DROP TECHNIQUE USING PLATELET CONCENTRATES Vs PERICARDIAL MEMBRANE WITH INJECTABLE PLATELET RICH FIBRIN IN CLASS I AND CLASS II GINGIVAL RECESSIONS-A PARALLEL ARM STUDY

Panineeya Mahavidyalaya Institute of Dental Sciences and research centre1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年2月21日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
14
试验地点
1
主要终点
Recession Height(RH)

研究概览

简要总结

To overcome problems associated with conventional periodontal surgery such as loss of tooth supporting tissue including papillae, along with associated postoperative pain,bleeding, swelling, root hypersensitivity and delayed healing, several minimally invasive techniques have been employed.
GUM DROP TECHNIQUE- is a papilla preservation technique, with a less invasive surgical approach utilizing platelet rich fibrin PRF as the graft material with improved treatment outcomes .It is an  alternative to the conventional treatments for gingival recession coverage

INJECTABLE PLATELET-RICH FIBRIN I-PRFis a liquid autologous platelet concentrate created by low-speed centrifugation at 700rpm for 3 min, omitting the formation of a PRF membrane. It harbors a variety of growth and differentiation factor, promotes angiogenesis, traps circulating stemcells, induces collagen synthesis, and stimulates the growth of fibroblasts and osteoblasts as well as prolongs the delivery of growth factors to the area where a wound is present.

ADVANCED PLATELET RICH FIBRIN A-PRF The fibrin clot that is derived from the centrifuged blood at 1300 rpm for 14 min becomes a membrane that can be used in place of autogenous connective tissue or acellular membranes in various procedures.

PERICARDIUM MEMBRANE - The pericardium membrane is derived from natural pericardium which has got a specific tridimensional structure with preserved links between collagen fibers and elastin. The pericardial membrane has got good biocompatibility and handling property with slow degradation rate. The source of this membrane could be bovine or porcine, with bovine membranes showing superior results.

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 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient aged more than 20 years with class I and class II gingival recessions.
  • 2.Patients having recession of one tooth or multiple teeth in maxilla or mandible.
  • 3.The Keratinized tissue width(KTW) should be more than 2mm.

排除标准

  • 1.Any systemic disease that contraindicates periodontal surgery or may affect healing.
  • 2.Current smokers 3.Pregnant and lactating mothers.
  • 4.History of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.

结局指标

主要结局

Recession Height(RH)

时间窗: BASE LINE,3 MONTHS AND 6 MONTHS

Recession width(RW)

时间窗: BASE LINE,3 MONTHS AND 6 MONTHS

Keratinized tissue width(KTW)

时间窗: BASE LINE,3 MONTHS AND 6 MONTHS

次要结局

  • Probing pocket depth(PPD)(Clinical attachment level(CAL))

研究者

发起方
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr K REKHA RANI

Panineeya Mahavidyala Institute of Dental sciences and research centre

研究点 (1)

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