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临床试验/NCT04561947
NCT04561947已完成不适用

Clinical Evaluation of the Treatment of Multiple Gingival Recessions with Connective Tissue Graft or Concentrated Growth Factor Membrane Using Tunnel Technique: a Randomized Controlled Clinical Trial

Bulent Ecevit University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Complete root coverage

研究概览

简要总结

This randomized controlled clinical study aimed to evaluate the success of the combination of tunnel technique and concentrated growth factor membrane for root coverage in treating multiple gingival recessions and compare with the gold standard connective tissue graft.

详细描述

The study included 108 defects in 40 patients with Miller Class I and II gingival recession. Gingival recession defects were randomly divided into two groups. Tunnel technique + connective tissue graft was applied to 20 patients in the control group (51 defects) and tunnel technique + concentrated growth factor membrane was applied to 20 patients in the test group (57 defects). The results at baseline and 6 months were evaluated for the following clinical parameters: Mean root coverage, complete root coverage, probing depth, clinical attachment level, gingival recession depth, gingival recession width, keratinized tissue width and gingival thickness.

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥18 years
  • periodontally and systemically healthy
  • presence of Miller I or II class gingival recession defect in at least two teeth on the buccal aspect of incisors, canine and premolar teeth (≥ 2 mm in depth)
  • gingival thickness ≥ 0.8 mm 2 mm apical to the gingival margin
  • presence of identifiable cementoenamel junction (CEJ) (step ≤1 mm at the CEJ level and/or presence of a root irregularity/abrasion with identifiable CEJ was accepted
  • full-mouth plaque score (FMPS) ≤20%.

排除标准

  • contraindications for surgical periodontal treatment
  • presence of recession defects associated caries, restoration and furcation problems
  • use of systemic antibiotics for any reason in the last 3 months.

结局指标

主要结局

Complete root coverage

时间窗: Six months

Change from baseline in percentage of complete root coverage at 6th months.

次要结局

  • Mean root coverage(Six months)
  • Probing depth(Six months)
  • Clinical attachment level(Six months)
  • Gingival recession depth(Six months)
  • Gingival recession width(Six months)
  • Keratinized tissue width(Six months)
  • Gingival thickness(Six months)

研究者

发起方
Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Umut BALLI

Associate professor

Bulent Ecevit University

研究点 (2)

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