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临床试验/NCT03140436
NCT03140436已完成不适用

Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders

Mahidol University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
The time required for complete removal of extrinsic stains

研究概览

简要总结

This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.

详细描述

Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.

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, Investigator)

盲法说明

Each group received treatment through a different operator (one operator per one group). Each patient was randomized using sealed envelopes according to treatment side (right or left) using powder grain size 65 µm or 40 µm. The patients and operators were blinded from the type of the powder.

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthy subjects who aged over 18 years old.
  • Subjects who have healthy periodontal health or gingivitis.
  • At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right & left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.
  • Intrinsic stain is not present.
  • Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.

排除标准

  • Pregnancy or current breastfeeding mother.
  • Allergy to sodium bicarbonate or the aroma of the powder

研究组 & 干预措施

sodium bicarbonate powders (65 µm)

Experimental

sodium bicarbonate powders with grain size 65 µm

干预措施: sodium bicarbonate powders with grain size 65 µm (Drug)

sodium bicarbonate powders (40 µm)

Experimental

sodium bicarbonate powders with grain size 40 µm

干预措施: sodium bicarbonate powders with grain size 40 µm (Drug)

结局指标

主要结局

The time required for complete removal of extrinsic stains

时间窗: 2 hr

Comparison of the time required for the complete removal of extrinsic stains by sodium bicarbonate powders with a grain size of 65 µm and 40 µm

次要结局

  • Patient acceptance(2 hr)
  • Operator opinion(2 hr)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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