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临床试验/NCT04124887
NCT04124887已完成不适用

Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月3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
发起方
入组人数
40
试验地点
1
主要终点
Monitoring mineralization changes

研究概览

简要总结

The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study was carried out in 40 healthy, high caries risk children (DMFS >8), aged six to seven years with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were divided randomly into four groups and the varnishes were applied to the determined teeth at baseline, one and three months. The same varnish was used, if there is more than one first molar to be applied of the same patient. The groups were comprised as follows:

Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35), Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group 3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of the patients were completed before the varnish application and oral hygiene instructions were given to all children at the start of the study.

Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2) and six months (T3). Within and between group comparisons were analysed statistically.

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
Double (Participant, Investigator)

入排标准

年龄范围
6 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subject has at least one fully erupted permanent first molar tooth

排除标准

  • Subject has a permanent first molar tooth with visible cavitation on the tooth surface Subject has a partially erupted permanent first molar tooth.

研究组 & 干预措施

Sodium fluoride

Active Comparator

Duraphat Varnish containing 5% Sodium fluoride

干预措施: Sodium Fluoride (Drug)

Tricalcium phosphate

Experimental

Clinpro™ White Varnish containing 5% NaF with TCP

干预措施: Tricalcium Phosphate (Drug)

Xylitol-coated calcium and phosphate

Experimental

Embrace ™ Varnish containing 5% NaF with CXP

干预措施: Xylitol-coated calcium and phosphate (Drug)

Casein phosphopeptide amorphous calcium phosphate

Experimental

MI Varnish containing 5% NaF with CPP-ACP

干预措施: Casein phosphopeptide amorphous calcium phosphate (Drug)

结局指标

主要结局

Monitoring mineralization changes

时间窗: One, three, six months

To monitor mineralization changes on permanent first molars, laser fluorescence scanning method was used with DiagnodentPen device.

次要结局

未报告次要终点

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Erkmen Almaz

Asist prof

Kırıkkale University

研究点 (1)

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