跳至主要内容
临床试验/NCT04032405
NCT04032405已完成不适用

Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects. A Controlled Randomized Clinical Trial.

Cukurova University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Keratized tissue height

研究概览

简要总结

Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF.

Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥19 years of age,
  • Periodontally and systemically healthy,
  • FMPS and FMBS <15%,
  • Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,

排除标准

  • Contraindications for surgery,
  • Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.

研究组 & 干预措施

CAF+CTG

Active Comparator

the combined connective tissue graft (CTG) with coronally advanced flap (CAF)

干预措施: CAF+CTG+i-prf (Procedure)

CAF+CTG+i-prf

Experimental

the combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)

干预措施: CAF+CTG+i-prf (Procedure)

结局指标

主要结局

Keratized tissue height

时间窗: six months

measured from the mucogingival junction to the gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre

gingival recession depth

时间窗: six months

the distance between the CEJ and gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre

次要结局

未报告次要终点

研究者

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

Mustafa Ozcan

Assistant Professor

Cukurova University

研究点 (2)

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