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临床试验/NCT04401826
NCT04401826已完成不适用

Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月6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
24
试验地点
1
主要终点
Pain VAS

研究概览

简要总结

Compare pain response following microsurgical conventional flap approach using Piezosurgery versus flapless approach for esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.

详细描述

The conventional approach: Anesthesia will be given followed by bone sounding using William graduated periodontal probe and measuring the pocket depth (using magnification loupes and microsurgical blades)

  • Marking the bleeding points
  • An internal bevel incision is made followed afterwards by a sulcular incision.
  • The gingival collar is eliminated.
  • Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery and an apical position of the bone 2-3mm beyond CEJ.
  • Mattress suture (6.0) is made

The intervention approach:

Surgery is done the same as in the conventional approach but without opening a flap, gaining access via a tunneling instrument and piezo tips for osteoplasty

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)

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

  • Patients with healthy systemic condition.
  • Adult patients ˃ 18 years old.
  • The presence of the six upper anterior teeth.
  • Patients who have short clinical crowns due to altered passive eruption classified as Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).
  • Absence of sites with attachment loss and probing depth (PD) >3 mm.
  • Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).
  • Compliance with good oral hygiene.
  • Patients accepts 6-months follow-up period (cooperative patients).
  • Patients provides an informed consent.

排除标准

  • Presence of prosthetic crowns
  • Extensive restorations
  • Extensive incisal edge attrition.
  • Smokers ˃ 10 cigarettes / day
  • Pregnant females

结局指标

主要结局

Pain VAS

时间窗: 48 hours

Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative

次要结局

  • Post-Surgical swelling(14 days)
  • Post-Surgical Patient Satisfaction.(6 months)
  • Mid-buccal gingival margin level(6 months)
  • Pink Esthetic Score(6 months)

研究者

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

Marie-line Sherif Sourour

Principal Investigator

Cairo University

研究点 (1)

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