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临床试验/NCT03514797
NCT03514797已完成4 期

Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching

André Luis Faria e Silva1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年4月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Time to tooth color satisfaction

研究概览

简要总结

This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good general and oral health;
  • Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

排除标准

  • Presence of non-treated caries or periodontal disease;
  • Prior tooth hypersensitivity;
  • Presence of gingival recession;
  • Teeth with cracked enamel or any hypoplasia;
  • Patients using oral removable or fixed orthodontic appliances;
  • Patients were pregnant or breastfeeding.

研究组 & 干预措施

Combined technique

Experimental

A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day.

干预措施: Bleaching Agents (Drug)

At-home bleaching

Active Comparator

The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.

干预措施: Bleaching Agents (Drug)

结局指标

主要结局

Time to tooth color satisfaction

时间窗: up to 1 month after beginning the tooth bleaching procedures

Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained

次要结局

  • Tooth sensitivity(1, 2, 3, and 4 week after beginning the tooth bleaching procedures)
  • Color change(up to 1 month after beginning the tooth bleaching procedures)

研究者

发起方
André Luis Faria e Silva
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

André Luis Faria e Silva

Principal Investigator

Universidade Federal de Sergipe

研究点 (1)

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