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临床试验/NCT07753512
NCT07753512尚未招募不适用

Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment: A Split Mouth Randomized Controlled Trial

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2027年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
34
试验地点
1
主要终点
Number of white spot lesions

研究概览

简要总结

The primary goal of this study is to compare the number of white spot lesions during fixed appliance therapy between self-etch and one-step bonding systems.

详细描述

The aim of this study is to compare the number of white spot lesions that appear around bonded brackets between self-etch and one-step bonding systems using visual examination and to compare amount of demineralisation using DIAGNOdent scores.

研究设计

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

入排标准

年龄范围
12 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • healthy patients 12-30 yrs
  • patients undergoing fixed appliance treatment with full mouth bonding
  • presence of at least 7 accessible teeth
  • no cavitated lesion at time of bond up

排除标准

  • patients with chronic or systematic diseases
  • patients with fluorosis or enamel defects
  • presence of fixed prosthesis
  • patients on medications which could alter salivary flow
  • patients with history of salivary gland disease

研究组 & 干预措施

Experimental 1: Self-Etch Adhesive

Experimental

Self- Etch Adhesive

干预措施: Self-etch adhesive (Combination Product)

Control Group

Placebo Comparator

Conventional bonding technique

干预措施: Conventional Bonding Technique (Combination Product)

Experimental group 2: One-Step Adhesive

Experimental

干预措施: One-Step Adhesive (Combination Product)

结局指标

主要结局

Number of white spot lesions

时间窗: From bracket placement to 6 months after placement.

Demineralisation of bonded teeth

时间窗: From date of bracket placement to 6 months of treatment

Amount of demineralisation around brackets measured

次要结局

未报告次要终点

研究者

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

Shoaib Rahim

Associate Professor

Foundation University Islamabad

研究点 (1)

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