此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Fissure Sealant Retention Trial (FSRT)

2009年4月1日 更新者：Aga Khan University

Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent

The aim of the investigators study is to compare how two different bonding agents affects retention in a preventive dental procedure of pit and fissure sealant. This study will help in deciding whether the self etch bonding agent requiring less steps in completion is as effective as the total etch bonding agent requiring multiple steps in fissure sealant placement.

研究概览

地位

未知

条件

干预/治疗

详细说明

Pit and fissure sealant have been hailed as a highly effective preventive dental treatment since it was introduced first in late 1970s . Sealants have traditionally placed using two step bonding agents based on acid etching with phosphoric acid followed by drying and bonding agent application and curing. Multiple steps in application of bonding agents have been associated with more chances of procedure errors and prolonged procedure time. The newer bonding agents are based on minimizing the number of steps involved with introduction of self etching bonding agents.6th generation adhesives are based on mixing of two components where as the 7th generation adhesives are based on no mix technique.

Previous studies on fissure sealants have focused on conventional etch and rinse bonding agents, there are only few published studies on effectiveness of the self etch bonding agents in retention of fissure sealants in vivo that have targeted the 6th generation adhesive. Feigal and Quelhas reported equivocal results with use of self etching bonding agents in comparison with etch and rinse bonding agents, but their study was limited by smaller sample size. Similar study was conducted by Burbridge which was based on short clinical follow up of 6 month evaluation where Xeno III by Dentsply (6th generation bonding agent) was compared with Prime & Bond (Dentsply). Another study by Venker et al on Adper Prompt L Pop in a school sealant program was based on retrospective review of cases. In light of published literature on (6th generation) self etch bonding agent has been found to be equal or inferior to total etch bonding agents (5th generation). There are no published clinical trials on the retentiong rate comparison of total etch bonding agent with no mix slef etch bonding agents in pit and fissure sealant.

Our study is based on comparison of effectiveness of single step bonding agent (7th generation adhesives) versus two step bonding agent in fissure sealant retention.

研究类型

介入性

注册 (预期的)

93

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴基斯坦
    • Sindh
      • Karachi、Sindh、巴基斯坦、3500
        • 招聘中
        • The Aga Khan University Hospital
        • 接触：
        • 首席研究员：
          • Nadia Aman, BDS
        • 副研究员：
          • Ali K Khuwaja, FCPS
        • 副研究员：
          • Farhan R Khan, FCPS

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

6年 至 25年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Fully erupted bilateral first or second permanent molar teeth.
  • Patients requiring fissure sealant due high caries risk.
  • Age group 6-25 years.
  • Occlusal fissures of molar teeth.

Exclusion Criteria:

  • Cases where one of the molar on either side is grossly carious or restored
  • Third molars
  • Uncooperative patients
  • Molar teeth with antagonist tooth not present or extracted
  • Mentally and physically handicapped patients

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：预防
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：1
application of total etch bonding agent ( 5th generation) for placement of resing based pit and fissure sealants.
其他：Total etch bonding agent (5th generation)

Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch and rinse bonding system (two step bonding agent) will be treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved.

Adper Single Bond 2 (3M ESPE) will be applied to occlusal fissure using applicator brushes followed by curing for 10 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.

其他名称：
  • Adper Single bond 3M ESPE
实验性的：2
Self etch bonding agent (7th generation) application for placement of resin based pit and fissure sealant
其他：Self etch (7th generation ) bonding agent
For teeth selected for application of self etching bonding agent (Adper Easy Bond 3 M), the bonding agent will be applied to occlusal surface with microbrushes and will be left undisturbed for 20 seconds followed by air drying for 5 seconds and then will be light cured for 10 seconds. Fissure sealant (Clinpro 3M ESPE) will be applied in a similar manner as for etch and rinse group and light cured.
其他名称：
  • Adper Easy Bond 3M ESPE

研究衡量的是什么？

主要结果指标

结果测量
大体时间
fissure sealant loss
大体时间：3months
3months

次要结果测量

结果测量
大体时间
fissure sealant loss
大体时间：6months
6months

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

Aga Khan University

调查人员

  • 首席研究员：Nadia Aman, BDS、The Aga Khan University Hospital

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

2009年1月1日

初级完成 (预期的)

2009年7月1日

研究完成 (预期的)

2009年10月1日

研究注册日期

首次提交

2009年4月1日

首先提交符合 QC 标准的

2009年4月1日

首次发布 (估计)

2009年4月2日

研究记录更新

最后更新发布 (估计)

2009年4月2日

上次提交的符合 QC 标准的更新

2009年4月1日

最后验证

2009年3月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 07GS028SUR

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅