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临床试验/NCT04409366
NCT04409366已完成不适用

One- Versus Two-Stage Aesthetic Crown Lengthening for Restorative Purposes: A Randomized Controlled Trial.

Universidad Complutense de Madrid0 个研究点目标入组 30 人开始时间: 2013年4月1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
30
主要终点
T1-T4

研究概览

简要总结

This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

详细描述

Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

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 (Outcomes Assessor)

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

  • older than eighteen years of age;
  • more than 20 teeth in the mouth;
  • with full mouth plaque and bleeding scores lower than 15%; and
  • without probing pocket depth and/or attachment loss >4 mm

排除标准

  • Pregnant women or breastfeeding
  • treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
  • currently undergoing orthodontic therapy

结局指标

主要结局

T1-T4

时间窗: Baseline-12 months

The difference in mm between the ideal gingival margin (T1) and the position of the gingival margin at 12 months (T4).

次要结局

  • Clinical Crown Length(At baseline, 6- and 12-month)
  • Gingival display upon smiling(At baseline, 6- and 12-month)
  • Amount of keratinized tissue(At baseline, 6- and 12-month)
  • Supracrestal tissue dimension(At baseline, 6- and 12-month)

研究者

申办方类型
Other
责任方
Sponsor

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