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临床试验/CTRI/2019/05/019306
CTRI/2019/05/019306已完成4 期

Comparative evaluation of remineralization efficacy Nanohydroxyapatite and Bioactive glass on demineralized enamel – An in situ study

Dr A Yogha Padhma1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年5月31日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
Vicker’s microhardness values

研究概览

简要总结

This is an in-situ study comparing theefficacy of biomimetic (nanohydroxapatite) and non biomimetic remineralizingagents (bioactive glass) on demineralized enamel slabs obtained from extractedhuman third molar teeth (cleaned and autoclaved).

In-Situstudy design: Theremineralization phase will take place in the oral cavity of healthy volunteersunder the influence of saliva.

Six healthy adultvolunteers (post graduate dental students) will take part in a 7 days in-situ studyafter giving consent.  They will wearacrylic palatal appliances, with each appliance containing two rows of three demineralizedenamel slabs. One row slabs will be treated using biomimetic remineralizationsystem (Nanohydroxyapatite - Group I) and the other row slabs will receivenon-biomimetic remineralization systems (Bioactive glass - Group II) for 7 days. A part ofthe enamel slab will serve as its own control (Baseline and demineralization).After the completion of remineralization cycle, Vickers microhardness values will be  calculated.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Participants with good oral hygiene, Participants with a salivary pH ranging between 6.8 – 7.2, Participants with salivary flow above 1.0ml/min Presence of atleast 22 natural teeth with no caries activity or periodontal disease.

排除标准

  • Participants with poor oral hygiene Participants with very high caries activity Participants with less than 22 teeth Participants on antimicrobial or any other treatment.

结局指标

主要结局

Vicker’s microhardness values

时间窗: 7 days after remineralization

次要结局

  • NA(NA)

研究者

发起方
Dr A Yogha Padhma
申办方类型
Other [self]

研究点 (1)

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