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临床试验/NCT03804086
NCT03804086Unknown不适用

Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects

Hadeer Ashraf Hassan Roushdy0 个研究点目标入组 28 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
28
主要终点
Relative Vertical Clinical Attachment Level (RVCAL)

研究概览

简要总结

this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.

In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient-related criteria:
  • Systemically healthy patients.
  • Compliance with oral hygiene instructions and the maintenance program provided.
  • Accepts the 6 months follow-up period.
  • Provide informed consent.
  • Teeth related criteria:
  • Mature permanent tooth.
  • Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
  • Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
  • Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

排除标准

  • Patient-related criteria:
  • Patients taking drugs known to interfere with periodontal wound healing in the last six months.
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Teeth related criteria:
  • Teeth with interproximal supra-bony or intrabony defects.
  • Teeth with gingival recession.
  • Teeth with grade II or III mobility.

研究组 & 干预措施

Test Group

Experimental

Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).

干预措施: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (Procedure)

Control Group

Active Comparator

Open flap debridement alone.

干预措施: Open flap debridement (Procedure)

结局指标

主要结局

Relative Vertical Clinical Attachment Level (RVCAL)

时间窗: 6 months

relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe

次要结局

  • Relative Horizontal Clinical Attachment Level (PHCAL)(6 months)
  • Probing Depth (PD)(6 months)
  • Gingival margin Level (GML)(6 months)

研究者

发起方
Hadeer Ashraf Hassan Roushdy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hadeer Ashraf Hassan Roushdy

Dentist

Cairo University

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