跳至主要内容
临床试验/NCT05031169
NCT05031169Unknown不适用

Evaluation of Surgical Management of Interdental Papilla Recession With Advanced Platelet Rich Fibrin Compared to Subepthelial Connective Tissue Graft. A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
papilla height

研究概览

简要总结

deficient interdental papillae witt be surgically reconstructed. in one group, connective tissue graft (SCTG) will be used for papillae augmentation, while in the other group, advanced platelet rich fibrin (A-PRF). the height of the papillae will be measured preoperatively as well as post operatively at 3, 6 ,9 and 12 months.

详细描述

The aim of this study is to compare the effect of A-PRF membrane to SCTG when used as grafting material with the Han and Takei's approach to reconstruct receding interdental papilla and assess deference in papilla height between the study groups.

The clinical parameters that will be evaluated are:

  • Papilla height (PH)
  • Clinical attachment level (CAL)
  • Probing depth (PD)
  • Post-operative patients' satisfaction about the esthetic outcome
  • Post-operative pain level among patients

Study settings:

This study will be conducted in the postgraduate periodontology clinics in the faculty of dentistry, Cairo University. The participants will be selected from the outpatient clinic of the department.

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

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

入选标准

  • Be healthy adults older than 18 years of age and presenting at least one deficient papilla with papilla presence index 2 or 3
  • Have Interproximal CAL ≤ 3 mm
  • Have probing depth ≤ 3mm
  • Distance between the alveolar bone crest and contact point is less than 7mm.

排除标准

  • Pregnancy and lactation.
  • Carious and non-carious cervical lesion in the involved teeth around the papilla.
  • Restoration in teeth around the papilla (filling, crown, bridge, facings, clasp of a partial denture).
  • Open contacts and non-vital teeth
  • Poor oral hygiene with plaque index > 20 %.
  • Tooth mobility
  • History of medication in the previous 3 months
  • History of periodontal surgery in the site to be treated in the past 12 months

结局指标

主要结局

papilla height

时间窗: base line , 3, 6, 9, and 12 months

change of papillae height will be recorded using a graduated periodontal probe (UNC 15 probe)

次要结局

  • patient satisfaction(3 and 12 months)

研究者

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

Sanabel Osama Omran Barakat

Ph d candidate

Cairo University

研究点 (1)

Loading locations...

相似试验