Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine - a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change of participant satisfaction with the tooth color
研究概览
简要总结
The study investigates the effect of toothbrushing with a toothpaste containing blue covarine compared to a control toothpaste without blue covarine on tooth color. Participants brush their teeth once with either the blue covarine containing toothpaste or a control toothpaste for two minutes. Before and after brushing, tooth color is assessed with a spectrophotometer. Moreover, satisfaction of the participants with their tooth color is assessed using a numeric analogue scale before and after treatment.
The null hypotheses are that neither brushing with the toothpaste containing blue covarine nor brushing with the control toothpaste change a) the tooth color and b) the satisfaction of the participants with their tooth color.
详细描述
Participants are recruited by advertizing in several public areas in Aarhus, Denmark.
Written and oral information on the study is provided, eligibility criteria are checked, and informed consent is given by the participants.
The upper front teeth of the participants are cleaned with pumice and a rubber cup by operator A.
Participants look at the color of their upper front teeth with a mirror, in a room with controlled lighting conditions.
Thereafter, participants rate their satisfaction with the color of their teeth using an 11-point aesthetic numeric analogue scale.
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, Investigator, Outcomes Assessor)
盲法说明
Participants are randomly assigned to one of the two arms and perform the treatment without knowing whether they use the blue covarine toothpaste or the control toothpaste. Treatment outcomes are assessed by a) a blinded operator and b) the blinded participants in a different room. Allocation of treatment groups will be revealed to the principal investigator after all data have been collected.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
排除标准
- •Dental caries in the upper front teeth
- •Intrinsic stain of the upper front teeth, including tetracyclin stains, fluorosis, and staining due to pulpitis or pulp necrosis
- •Dental restorations in the upper front teeth, including fillings, veneers, crowns, and root canal fillings
- •Dental anomalies of the upper front teeth, including molar incisor hypomineralisation, amelogenesis imperfecta, and dentinogenesis imperfecta
结局指标
主要结局
Change of participant satisfaction with the tooth color
时间窗: Participant satisfaction is assessed twice, right before (baseline) and immediately after toothbrushing.
Change of participant satisfaction with the color of their upper front teeth is assessed after toothbrushing compared to baseline using an 11 step aesthetic numeric analogue scale (ANA scale, Funk et al., 2011; DOI: https://doi.org/10.1016/j.jcms.2011.07.018).
3D VITA SYSTEM 3D-MASTER tooth color change
时间窗: Tooth color is measured twice, right before (baseline) and immediately after toothbrushing.
Tooth color change of the upper right first incisor is assessed after toothbrushing compared to baseline using a spectrophotometer.
次要结局
- Change of blue-yellow color component of the tooth (b* in the CIELAB color space)(The blue-yellow color component is assessed twice, right before (baseline) and immediately after toothbrushing.)
- Change of the green-red color component of the tooth (a* in the CIELAB color space)(The green-red color component is assessed twice, right before (baseline) and immediately after toothbrushing.)
- Change of the tooth lightness value (L* in the CIELAB color space)(The tooth lightness is assessed twice, right before (baseline) and immediately after toothbrushing.)
- Participant evaluation of tooth color change(The color change of the upper front teeth is assessed once: immediately after toothbrushing.)