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临床试验/NCT06834464
NCT06834464已完成不适用

Effect of Nanohydroxyapatite Paste After Different Pretreatment Techniques on Remineralization and Color Change of White Spot Lesions In Children: A Randomized Control Study.

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月5日最近更新:
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
Assessment of color change

研究概览

简要总结

forty teeth diagnosed with white spot lesions in children aged between 10-14 years old were selected to compare between the effect of using nanohydroxyapatite paste applicatio either alone or preceded by the application of HCl (hydrochloric acid) or microabrasion

详细描述

This study was designed as a randomized controlled double blinded clinical trial in which forty teeth clinically diagnosed with white spot lesions collected from children of both sexes with age range between 10-14 years old was selected from the outpatient clinics of the National Research Centre.

Ethical approval was obtained from the Medical Research Ethics Committee, National Research Centre with number 0343 Written informed consent was taken from the legal guardian of each participating child willing to participate in the trial, prior to the start of the clinical procedure after explaining the whole procedure in a simple way. The consent form was written in Arabic. verbal approval was taken from the child . Parallel allocation design was adopted for the intervention and control arms with allocation ration 1: 1 (i.e. 10 cases each).

The sample size was calculated considering the previously published studies with 80% power in detecting the true statistical significance among the four groups.

The inclusion criteria dictated that the patients should be in the age range of 10 to 14 years, presenting at least 1 White spot lesion on the labial surface of one or more permanent upper or lower anterior teeth.

The exclusion criteria involved patients who had hypoplastic enamel and those with dentine caries, patients who had systemic diseases and also uncooperative patients.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Blinding was done to the outcomes assessor and the child and care provider. the outcome assessor has assessed the outcome of each treatment without knowing the type of treatment done. the child was blinded as he was not aware of the type of treatment applied to him. The care provider was blind and he was not allowed to accompany the child during treatment application

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Nano hydroxyapatite paste group

Experimental

Nano hydroxyapatite paste was applied for 5 minutes

干预措施: Nanohydroxyapatite paste (Drug)

HCl + Nano hydroxyapatite paste

Experimental

Pretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes.

干预措施: Nanohydroxyapatite paste (Drug)

HCl + Nano hydroxyapatite paste

Experimental

Pretreatment with 2% HCL for 20 sec then nano hydroxyapatite paste was applied for 5 minutes.

干预措施: HCl liquid (Drug)

microabrasion + Nano hydroxyapatite paste

Experimental

Pretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste was applied for 5 minutes.

干预措施: Nanohydroxyapatite paste (Drug)

microabrasion + Nano hydroxyapatite paste

Experimental

Pretreatment with microabrasion with oplasture for 60 sec then nano hydroxyapatite paste was applied for 5 minutes.

干预措施: microabrasion (Drug)

结局指标

主要结局

Assessment of color change

时间窗: Color change of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups

Color change of white spot lesions was assessed; the onset of treatment on each tooth in each of study groups and control group using Vita easy shade device.

次要结局

  • Remineralization assessment All the teeth of the patients included in the study will be examined using DIAGNOdent® (KaVo) as recommended by the manufacturer to assess the remineralization process.(Remineralization of white spot lesions was assessed; before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment on each tooth in each of study groups)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maryam Mohamed Ibrahim El Mansy

Researcher of Pediatric Dentistry, Orthodontics and Pediatric Dentistry Department, Oral and Dental Research Institute

National Research Centre, Egypt

研究点 (1)

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