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临床试验/NCT05644860
NCT05644860进行中(未招募)不适用

Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates

Foundation University Islamabad2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Bracket failure rate

研究概览

简要总结

This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)

详细描述

Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.

Nanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.

The aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.

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 (Participant)

盲法说明

The two materials being compared look similar and according to the manufacturers' instructions they are applied using a similar protocol i.e. enamel conditioning, application of unfilled resin, placement of brackets and light curing. Hence the patient will not be able to identify as to which experimental group they are placed in.

入排标准

年龄范围
12 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having treatment with fixed metallic orthodontic appliances
  • Patients in whom both upper and lower arches are bonded in single visit

排除标准

  • Patients with variations in morphology of teeth
  • Patients with defective enamel, dentine and cementum
  • Patiens with parafunctioal habits
  • Patients with restorations involving the facial surface of teeth

结局指标

主要结局

Bracket failure rate

时间窗: 6 months

Number of brackets detached from the tooth surface

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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