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临床试验/NCT02335866
NCT02335866已完成早期 1 期

Platelet Rich Fibrin Against Connective Tissue Graft in Treatment of Gingival Recessions

Necmettin Erbakan University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Gingival recession depth

研究概览

简要总结

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment

详细描述

Purpose

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) in the treatment of multiple gingival recessions. Furthermore the second aim of the present study was to compare plastic periodontal surgical procedure, with PRF membrane and connective tissue graft, by a randomized splitmouth controlled study.

Clinical effectiveness of platelet-rich fibrin (PRF) in combination with modified coronally advanced flap (MCAF) as measured by Clinical measurements.

Material and Methods

Twenty patients with multiple gingival recession defects (Miller I, II) participated in this split-mouth trial. Sixty defects received either MCAF+PRF (test) or MCAF with subepithelial connective tissue graft (SCTG) (control). Gingival recession depth (RD), gingival recession width (RW), keratinized tissue width (KTW), recession area (RA), probing depth (PD), clinical attachment level (CAL) and gingival thickness (GT) were evaluated at baseline and 6 months. Additionally post-surgery patient satisfaction and pain status were measured by comparing visual analogue scale (VAS) scores.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • non smoking,
  • similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
  • identifiable cemento-enamel junction (CEJ),
  • age ≥18 years,
  • presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
  • no periodontal surgical treatment on the involved sites,
  • sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

排除标准

  • Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
  • Molar, mobile or fully restorated teeth

结局指标

主要结局

Gingival recession depth

时间窗: 6 months

Change from baseline in gingival recession will be assessed at 6 months

Complete root coverage

时间窗: 6 months

Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.

次要结局

  • Keratinized tissue width(6 months)
  • Pain scores(first week after operations)

研究者

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

ELİF ONCU

Assist.Prof.Dr.

Necmettin Erbakan University

研究点 (2)

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