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Esthetic Outcomes of Single Immediate Implant Placement

2019年4月26日更新者：Elena Sanz Miralles、Columbia University

Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques

A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.

研究概览

地位

完全的

条件

干预/治疗

详细说明

In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap.

In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures.

In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.

研究类型

介入性

注册 (实际的)

阶段

不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Single non-restorable tooth in the anterior maxilla
Intact buccal plate or <5mm fenestration

Exclusion Criteria:

Pregnancy
Current smokers >10 cigarettes/day
Parafunctional habits
Malocclusion or intent of orthodontic therapy in the future
Severe periodontal disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Flapless immediate implant placement group Flapless placement of immediate implant and temporary crown	程序：Flapless immediate implant placement Experimental group: No elevation of flap prior to immediate implant placement 设备：Implant and temporary crown Both groups receive this intervention
有源比较器：Flap assisted immediate implant placement group Flap elevation prior to placement of immediate implant and temporary crown	设备：Implant and temporary crown Both groups receive this intervention 程序：Flap assisted immediate implant placement Control group: Flap will be elevated prior to immediate implant placement

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline 大体时间：Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months	Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months

次要结果测量

结果测量	措施说明	大体时间
Change in Buccal Horizontal Ridge Dimensions 大体时间：Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months	Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.	Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
Change in Interproximal Crestal Bone Levels 大体时间：Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months		Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

调查人员

首席研究员：Elena Sanz Miralles, DDS, MS, PhD、Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年12月1日

初级完成 (实际的)

2016年8月9日

研究完成 (实际的)

2016年8月9日

研究注册日期

首次提交

2015年4月15日

首先提交符合 QC 标准的

2015年5月1日

首次发布 (估计)

2015年5月6日

研究记录更新

最后更新发布 (实际的)

2019年5月3日

上次提交的符合 QC 标准的更新

2019年4月26日

最后验证

2019年4月1日

Esthetic Outcomes of Single Immediate Implant Placement