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临床试验/NCT04637451
NCT04637451已完成不适用

The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

Okan University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年7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
16
试验地点
2
主要终点
Change from Baseline Keratinized Gingiva Height at 6 month

研究概览

简要总结

The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

详细描述

Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

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

  • Systemic healthy individuals
  • Presence Miller's class I and II gingival recession in the anterior and premolar teeth

排除标准

  • Age <18 years
  • Pregnancy
  • Lactation
  • Any cardiovascular, renal or hepatic conditions
  • History of periodontal surgery
  • Tooth mobility
  • Presence of probing depth >3 mm and caries or restorations in the teeth undergoing treatment

结局指标

主要结局

Change from Baseline Keratinized Gingiva Height at 6 month

时间窗: Baseline and month 6.

Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)

Change from Baseline Gingival Recession Depth at 6 month

时间窗: Baseline and month 6.

The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)

次要结局

  • Change from Baseline Pain at 2 week(Baseline and week 2.)
  • Change from Baseline Patient Satisfaction at 6 month(Baseline and month 6.)
  • Change from Baseline Root Hypersensitivity at 6 month(Baseline and month 6.)
  • Change from Baseline Pain at 1 week(Baseline and week 1.)

研究者

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

Sibel Kayaalti-Yuksek

Assistant Professor

Okan University

研究点 (2)

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