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临床试验/NCT07042204
NCT07042204已完成不适用

Effectiveness of Extended Platelet-Rich Fibrin (ePRF) Alone and in Combination With Bioactive Glass Nanoparticles in the Treatment of Grade II Furcation Defects

Merna Nasser Mohamed Mostafa Ibrahim Elnahas1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
The primary outcome will be the amount of bone fill vertically and horizontally obtained in the treatment of grade II furcation defects calculated from CBCT data in millimeters

研究概览

简要总结

The aim of the study is to evaluate and compare the effectiveness of extended platelet-rich fibrin (ePRF) alone and in combination with bioactive glass nanoparticles in the treatment of grade II furcation defects clinically and radiographically.

详细描述

A total of 30 grade II furcation defects will be randomly divided into three groups as follows:

Group I: 10 grade II furcation defects will be treated by extended platelet-rich fibrin (ePRF) alone.

Group II: 10 grade II furcation defects will be treated by bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF).

Group III: 10 grade II furcation defects will be treated by bioactive glass nanoparticles with collagen membrane.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of Glickman's grade II furcation defects in molars probing depth (PD) ≥5 mm horizontal PD ≥3 mm.
  • The patients are in good systemic health and had not undergone any periodontal surgery in the areas to be treated within the prior 12 months.

排除标准

  • Smokers and tobacco chewers.
  • Patients that take any medications within the past 6 months that could alter their periodontal status.
  • pregnant or lactating females.
  • Patients with known allergy to materials or drugs that will be used or prescribed in this study.

研究组 & 干预措施

Group I

Experimental

10 grade II furcation defects will be treated by extended platelet-rich fibrin (ePRF) alone.

干预措施: Group I (extended platelet-rich fibrin) (Procedure)

Group II

Experimental

10 grade II furcation defects will be treated by bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF).

干预措施: Group II (bioactive glass nanoparticles mixed with extended platelet-rich fibrin) (Procedure)

Group III

Active Comparator

10 grade II furcation defects will be treated by bioactive glass nanoparticles with collagen membrane.

干预措施: Group III (bioactive glass nanoparticles and covered by a collagen membrane) (Procedure)

结局指标

主要结局

The primary outcome will be the amount of bone fill vertically and horizontally obtained in the treatment of grade II furcation defects calculated from CBCT data in millimeters

时间窗: 6 months follow up

次要结局

  • the secondary outcomes include improvements (decrease)of probing depth in millimetres(3 and 6 months follow up)
  • the secondary outcomes include improvements (decrease)of clinical attachment level loss in millimetres(3 and 6 months follow up)
  • the secondary outcomes include improvements (decrease) of gingival recession measured in millimetres(3 and 6 months follow up)
  • the secondary outcomes include improvements (decrease) of gingival bleeding index(3 and 6 months follow up)

研究者

发起方
Merna Nasser Mohamed Mostafa Ibrahim Elnahas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merna Nasser Mohamed Mostafa Ibrahim Elnahas

BDS, Clinical demonstrator, Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department

Mansoura University

研究点 (1)

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