Evaluation of Sensitivity and Color Change of Different Protocols of In-office Dental Bleaching
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tooth sensitivity
研究概览
简要总结
Clinical randomized single-blind trial, used to measure the level of tooth sensitivity (TS) after in-office dental bleaching sessions, on volunteers using a modified visual analog scale (VAS). The investigators selected for this study, 40 participants with color 2M2 or darker (Using OM1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with a 40% hydrogen peroxide gel with a 1-week interval. Participants were enrolled in two groups. In one group, the bleaching product was used according to manufacturer's instructions (40-minutes application in each section). In the other group, the bleaching product was used in two 20-minutes applications in each section.The investigators recorded the TS up to 48h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The risk and intensity of TS and the color change were compared between the two groups.
详细描述
Two weeks before the bleaching procedures, selected volunteers from the city of Nova Friburgo, (Rio de Janeiro, Brazil) received a dental screening and a dental prophylaxis with pumice and water in a rubber cup and signed an informed consent form.
This was a randomized, single-blind (evaluators), parallel and equivalence trial with an equal allocation rate between groups.
A total of 71 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria. A total of 40 participants were included in this study. The participants were randomly divided in the 40-minutes or 2x20-minutes groups.
During the in-office sessions, participants had the gingival tissue isolated of the teeth using a light-cured resin dam (Opal Dam, Ultradent Products International, Salt Lake, Utah, USA). After that, the 40% hydrogen peroxide gel (Opalescence Boost, Ultradent) was applied in one 40-min application according to the manufacturer's directions in all upper and lower incisors, canines and premolars, or was applied in the same teeth, but during 2 x 20-min applications, with no interval between them. After 20 minutes, the bleaching gel was removed with water spray before the second 20 minutes application. After 7 days this procedure was repeated using the same protocols.
Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective (value oriented shade guide Vita Lumin, Vita Zahnfabrik, Bad Sackingen, Germany) and an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). Color evaluation was done in a room under artificial lightning conditions without interference from outside light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The selected volunteers should:
- •Present Good general state of health
- •Be at least 18 years of age
- •Have an acceptable oral hygiene
- •Present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
- •Have anterior teeth with any kind of restoration.
- •Be No smoker
- •Have the upper right canine with color 2M2 or darker
排除标准
- •The selected volunteers should not:
- •Have medical history of diseases that can affect the results of the study
- •Have made use of cigarettes in the last 30 days
- •Have some important pathology in the oral cavity
- •Be pregnant
- •Be breastfeeding
- •Have moderate advanced periodontal disease;
- •Have consumed drugs, alcool or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
- •Have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product
- •Present gingival recession
- •Present exacerbated hypersensitivity history
研究组 & 干预措施
Bleaching 40 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.
干预措施: Standard in-office tooth bleaching (Procedure)
Bleaching 2x20 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed (with water) and a new application of 20 minutes will be made.
干预措施: Alternative in-office tooth bleaching (Procedure)
结局指标
主要结局
Tooth sensitivity
时间窗: 1 hour after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
Tooth sensitivity
时间窗: 24 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
Tooth sensitivity
时间窗: 48 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
次要结局
- Color change with scale(30 days after dental bleaching session)
- Color change with spectrophotometer(30 days after dental bleaching session)
研究者
Marcos de Oliveira Barceleiro
Full Professor
Universidade Federal Fluminense