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临床试验/NCT04606043
NCT04606043已完成不适用

Evaluation of the Effectiveness of Enamel Surface Treatment Using Sandblasting on the Bond Strength in the Rebonding Process: a Randomized Controlled Trial

Damascus University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年6月20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
20
试验地点
2
主要终点
Bonding Failure Rate

研究概览

简要总结

Patients at the Orthodontic Department of University of Aleppo Dental School will be selected if they meet the inclusion criteria then fixed orthodontic treatment with 0.018-inch slot MBT appliances will be applied for those patients.

The aim of this study is to compare Two rebonding procedures by applying a split-mouth design. The clinical failure rates of the two rebonding procedures will be evaluated.

详细描述

The sample of this study will be chosen after examination of patients referred to the Department of Orthodontics at the University of Aleppo Dental School then subjects who meet the inclusion criteria will be included in this trial.

An information sheet will be given to each possible candidate. Then consent forms will be obtained.

All patients will receive both rebonding procedures by applying split-mouth design. Each patient will be asked to select an opaque sealed envelope from a box with 20 ones. Ten envelopes will Include instructions for applying sandblasting prior to acid-etching on the right upper premolars and acid-etching alone on the left upper premolars. In contrast, the other ten envelopes will include opposite instructions.

A total sample of 80 premolars will be obtained to study the clinical failure rates of the two rebonding procedures.

The 80 premolars will be randomly divided into two groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • good general health and oral hygiene
  • willing and able to comply with the trial procedures
  • No crossbite, scissor bite, or occlusal interferences with the bonded/rebonded brackets in the premolars region (to prevent any potential early bond failure)
  • no craniofacial anomalies.

排除标准

  • any type of pervious orthodontic therapy
  • any need for ortho-surgical treatment or teeth extraction.

结局指标

主要结局

Bonding Failure Rate

时间窗: After six month exactly of bonding the brackets onto the surfaces of the teeth

Number of brackets loosing their bond to the enamel during the observation period divided by the total number of braces being applied.

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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