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临床试验/NCT02018120
NCT02018120已完成不适用

Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions

Ege University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Mean root coverage percentage

研究概览

简要总结

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

详细描述

The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.

Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.

Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.

Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.

Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.

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

  • Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
  • Identifiable CEJ on all teeth
  • Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
  • No past surgical treatment history of affected area.
  • Gingival thickness ≥ 0,8 mm for recession areas.
  • Sufficient palatal donor tissue for connective tissue harvesting.

排除标准

  • Pregnancy or lactation
  • Systematic diseases that may affect outcomes of periodontal therapy
  • Self-reported antibiotic medication within three months
  • Occlusal trauma in treatment site

结局指标

主要结局

Mean root coverage percentage

时间窗: 6 months

mean area of root coverage achieved by surgical root coverage therapy.

complete root coverage percentage

时间窗: 6 months

percentage of gingival recession defects completely covered by flaps after 6 months

次要结局

  • keratinized tissue width(6 months)
  • gingival tissue thickness(6 months)

研究者

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

Asude Merve Polat

PhD

Ege University

研究点 (2)

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