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临床试验/NCT04013659
NCT04013659Unknown1 期

Effect of Gel Renewal During In-office Dental Bleaching Using Violet LED Light as Photo-accelerator. A Randomized Blind Clinical Trial

Universidade Ibirapuera2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
33
试验地点
2
主要终点
Teeth Color 1

研究概览

简要总结

Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good oral hygiene conditions
  • Good general health conditions and without systemic disease
  • Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns
  • Patients with dental color A3 or darker, according to the VITA * Classical Color Scale.

排除标准

  • Pregnant and lactating female patients
  • Presence of caries, periodontal disease or any other infectious source in the oral cavity
  • Systematic use of tobacco and alcoholic beverages
  • Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching
  • Patients with dentin hypersensitivity
  • Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment.
  • Volunteers who use removable prostheses

研究组 & 干预措施

G1 - Permanence of the Whitening Gel

Experimental

Permanence of the Whitening Gel (Biological Product: 35% Hydrogen Peroxide) on the tooth enamel during the 15 minutes of dental-bleaching

干预措施: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation (Other)

G2 - Renewal of the Whitening Gel

Experimental

3 Whitening Gel (Biological Product: 35% Hydrogen Peroxide) renewal every 5 minutes during the 15 minutes of dental-bleaching

干预措施: Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation (Other)

结局指标

主要结局

Teeth Color 1

时间窗: 2 months after treatment

assessed quantitatively by colorimetric color scale

Teeth Color 2

时间窗: 2 months after treatment

assessed quantitatively by spectrophotometry

次要结局

  • Dental sensitivity(2 months after treatment)

研究者

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

Karen Müller Ramalho

Full Professor

Universidade Ibirapuera

研究点 (2)

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