跳至主要内容
临床试验/NCT05494294
NCT05494294已完成不适用

Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?

Hacettepe University2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2021年7月4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
Recession reduction

研究概览

简要总结

In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.

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)

盲法说明

Patients were randomly assigned into intraorally de-epithelialization group (n=25) and extraorally de-epithelialization group (n=25) groups by one of the authors with an allocation ratio of 1:1 using a computer-generated program after successful completion of the phase I periodontal treatment. One calibrated author masked the applied 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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single tooth recession more than 2mm
  • Gingival thickness less than 1mm

排除标准

  • unstable endodontic conditions or presence of any restoration/abrasion,
  • tooth mobility, any surgical history or gingival enlargement in the area,
  • uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

结局指标

主要结局

Recession reduction

时间窗: 12th month

RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

次要结局

  • amount of deciduous cells(at the day of the surgery.)
  • Gingival Thickness (GT)(12th month)
  • percentage of deciduous cells(at the day of the surgery)
  • Recession Depth (RD)(12th month)
  • Keratinized Tissue Height (KTH)(12th month)
  • Recession width (RW)(12th month)
  • Probing pocket depth (PD)(12th month)
  • Clinical attachment level (CAL)(12th month)
  • Keratinized tissue change (KTC)(12th month)
  • Wound healing index (WHI)(12th month)
  • Aesthetics (A)(12th month)
  • Tissue appearance (TA)(12th month)
  • Dentine hypersensitivity (DH)(12th month)
  • Vestibuler Depth(12th month)

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)

Loading locations...

相似试验