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临床试验/NCT05777811
NCT05777811已完成不适用

Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth

Hacettepe University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Vestibule depth 2

研究概览

简要总结

In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

详细描述

Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Patients were randomly assigned to either the Vertically Coronally Advanced Flap (n=25) group or the Free Gingival Graft (n=25) group by one of the authors, with an allocation ratio of 1:1, using a computer-generated program after the successful completion of Phase I periodontal treatment. One calibrated author applied the surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • full-mouth plaque and bleeding scores <15%
  • the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
  • the presence of an identifiable cemento-enamel junction

排除标准

  • Vestibule depth > 6mm
  • Smoking > 10 cigarettes per day
  • Any contraindications for periodontal surgery
  • Unstable endodontic conditions or presence of any restoration.

结局指标

主要结局

Vestibule depth 2

时间窗: 12th month.

The distance between the free gingival margin and the most apical point of the vestibul.

Vestibule depth 1

时间窗: 12th month

The distance between the free semento-enamel junction and the most apical point of the vestibul.

次要结局

  • Recession depth (RD)(12th month.)
  • Probing depth (PD)(12th month.)
  • Clinical attachment level (CAL)(12th month.)
  • Gingival thickness (GT)(12th month.)
  • Dentine hypersensitivity (DH)(6th week)
  • Wound healing index (WHI)(2nd week)
  • Tissue appearance (TA)(6th week)
  • Keratinized tissue height (KTH)(12th month.)
  • Patient expectations (PE)(6th week)
  • Aesthetics (A)(6th week)

研究者

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

Gencay Keceli

Assoc. Prof. Dr.

Hacettepe University

研究点 (2)

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