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临床试验/NCT07818655
NCT07818655已完成不适用

Effect of Diode Laser and Dye With Remineralizing Agent on Surface Area of White Spot Lesions by Using Digital Subtraction Radiograph Techniques. Randomized Clinical Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年5月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
surface area measurement white spot lesion (image anylsis)

研究概览

简要总结

The current study was conducted to compare effect of diode laser and perio green dye with reminerlizing agent on surface area white spot lesions by using digital subtraction radiographic techniques.

详细描述

A single-blinded, parallel-group, randomized clinical trial design was followed. 90 teeth with white spot lesions (WSLs) were selected from 30 patients. The participants were randomly assigned into six groups (n=15/group) according to the applied treatment agent (Remin Pro, X Pur Remin, and Pro-fluoride varnish) with diode laser (an average power of 1W, Exposure time of 10 s, diode 810 nm, speed of 1 mm/sec), and Elexxion Perio Green dye or without diode laser

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 (Investigator)

入排标准

年龄范围
13 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The patients should be 13e40 years old. The patients should have good oral hygiene, general health, and no systemic disease.

排除标准

  • presence of enamel hypoplasia, dental fluorosis, and carious cavity. These patients have diminished salivary flow or significant tooth wear, and concurrent participation in other clinical trials

研究组 & 干预措施

fluoride group

Active Comparator

The first group (A1B1): The teeth with WSLs were treated with fluoride varinsh with laser application.

干预措施: remin pro (Drug)

The teeth with WSLs were treated with Remin Pro with laser application

Active Comparator

The teeth with WSLs were treated with Remin Pro with laser application. The second group (A1B2): The contralateral teeth were treated with Remin Pro without laser application.

干预措施: remin pro (Drug)

Xremin pur

Active Comparator

The teeth with WSLs were treated with Xremin pur with laser application.

干预措施: remin pro (Drug)

结局指标

主要结局

surface area measurement white spot lesion (image anylsis)

时间窗: one month

The I sensor was a USP-driven digital sensor intended to acquire dental intraoral radiograph images. It was combined with the customized poisoning device supplied with the system. One month after the finalization of the remineralization protocol, another radiographic examination was undertaken. Before subtraction, gamma correction was applied to standardize the density and contrast, and images were obtained and saved as Tagged Image File Format (TIFF) and jpg. used image software for each area (Image J software), and follow-up images were subtracted from the base

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

Amani abdullah Omar bin shahna

Al-Azhar University

Faculty of Dental Medicine for Girls

研究点 (1)

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