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临床试验/NCT03695549
NCT03695549Unknown不适用

Root Coverage After the Use of Coronally Advanced Flap With Advanced Platelet Rich Fibrin (A- PRF) Compared With Subepithelial Connective Tissue Graft in Management of Miller Class I and II Gingival Recession. A Randomized Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2018年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
root coverage

研究概览

简要总结

patients with Miller class I , II gingival recession will be divided into 2 groups (control, intervention).the control one will receive coronally advanced flap with subepithililal connective tissue graft harvested from the palate while the intervention one will have coronally advanced flap with advanced platelet rich fibrin(A-PRF).as it represent a new generation of platelet concentrate allow for better healing and root coverage results.

Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference in amount of root coverage (mm) following the application of SCTG+A-PRF compared to CAF+SCTG.

详细描述

  • Population (P): Patients with single Miller class I, II gingival recessions.
  • Intervention (I): Coronally advanced flap (CAF) plus platelet rich fibrin (A-PRF).
  • Comparator (C): Coronally advanced flap (CAF) plus subepithelial connective tissue graft (SCTG).
  • Primary Outcome (O): Root coverage (mm).
  • Time frame: 9 months.
  • Study design: Randomized controlled clinical trial.
  • Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology-Cairo University

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients 18 years old and older both males and females.
  • Good oral hygiene after phase I therapy.
  • Miller's class I or II gingival recession.
  • Not using antibiotics, steroids, chemotherapy or other medications that may modify results of the surgery and healing.
  • Cooperative patients able and accept to come for follow up appointments

排除标准

  • Pregnant or lactating females.
  • Current Smokers.
  • Patients with any systemic disease that may affect the periodontal healing.
  • Teeth with endodontic treatment, buccal restoration or caries.
  • Patients with poor oral hygiene

研究组 & 干预措施

intervention

Active Comparator

CAF+ APRF

干预措施: CAF + (A-PRF) (Procedure)

control

Active Comparator

CAF+SCTG

干预措施: CAF+SCTG (Procedure)

结局指标

主要结局

root coverage

时间窗: 9 months

measured in millimeter

次要结局

  • Probing depth(9 months)
  • Clinical attachment level(9 months)
  • Recession width(9 months)
  • Gingival esthetics(9 months)
  • Width of keratinized gingiva(9 months)
  • Gingival thickness(9 months)
  • Post-operative pain(measured daily for the first 2 weeks post- operatively.)
  • Early wound healing(1,2,4 weeks post- surgical)
  • Patient Satisfaction(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

heba samir

assistant lecturer

Cairo University

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