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临床试验/NCT04407910
NCT04407910已完成4 期

Effects of Pre-operative Air-powder Polishing and Rubber-cup Prophylaxis on Tooth Bleaching Outcomes: Randomised Controlled Split-mouth Clinical Study

Cukurova University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
23
试验地点
2
主要终点
ΔE

研究概览

简要总结

The increasing demand for whitening teeth necessitates requirements and guidelines to ensure the efficacy of products and bleaching techniques. So far there is no comparative study to evaluate the effectiveness of pre-operative air-powder polishing device (APD) and rubber-cup prophylaxis on tooth bleaching in-office. Office-bleaching has some advantages such as avoiding soft tissue irritation, preventing the use of excess material and producing immediate esthetic results.

The aim this study is to compare the effects of pre-operative air-powder polishing and rubber-cup prophylaxis on tooth bleaching outcomes. The null hypothesis of this research was that there would be no difference in the change in according to the type of prophylaxis on tooth-bleaching outcomes.△L,△a,△b,△E and △SGU.

The results of the study show that both rubber cup prophylaxis and APD devices can be equally used before bleaching treatment as there were no statistical differences in color change.

详细描述

Tooth color was measured using spectrophotometer VITA Easyshade V (Vita Zahnfabrik, Germany). The spectrophotometer was calibrated before use in each participant and the device tip was placed on middle thirds of the labial surface of teeth as suggested by the manufacturer's manual.

The tooth color was measured before initial prophylaxis (baseline), immediately after bleaching and after one week. The digital spectrophotometer used in the current study measures the shade of teeth based on the CIE (Commission Internationale de l'éclairage) L*a*b* color space system. This system expresses color as three values: L* for the lightness from black (0) to white (100), a* from green (-) to red (+), and b* from blue (-) to yellow (+). The following values were recorded in the units of CIE L*a*b* color space.

-Data of lightness (L*) and a* and b*axis

-△e: a teeth color change (△e*) was derived as: △e = [(△L *)2+ (△a *)2 + (△b *)2]1/2 While making Shade guide units (SGU) measurements, the bleached index is set according to the VITA Bleached guide 3D-MASTER at spectrophotometer for the measured shade. The measured bleached index after treatment was subtracted from the baseline value. The difference corresponded to the change of the SGU (△ SGU) achieved immediately and 1 week after the bleaching treatment.

The patients had bleaching treatment on the maxillary anterior area including right and left canines. The right and left sides of the patients were randomized by toss of a coin to receive polishing with rubber cup prophylaxis or air powder polishing system before bleaching.

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
Single (Participant)

盲法说明

Single blind participant

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - being at least 18 years of age
  • having minimum of 20 natural teeth (including incisors, canines, and premolars in both arches)
  • having good oral hygiene (Plaque index <1, Gingival index <1)

排除标准

  • having restorations or active caries on the anterior teeth of either arch
  • presence of tetracycline staining or fluorosis
  • general hypersensitivity
  • gingival recession or periodontal disease
  • pregnant or lactating women
  • history of prior bleaching treatment

结局指标

主要结局

ΔE

时间窗: 1 week

Delta E is a metric for understanding how the human eye perceives color difference

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

zeliha gonca bek kurklu

assistant professor

Cukurova University

研究点 (2)

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