Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening: Double Blind Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 主要终点
- The analysis of the reduction of sensitivity using the toothpaste during whitening.
研究概览
简要总结
Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity.
Objective: To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray, reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening, through a controlled double-blind clinical study.
Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30 years of age, without gender distinction, who underwent in-office dental whitening using 35% hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with a one-week interval between them. The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The data were submitted to the multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test with a 5% probability level to differentiate the groups. In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
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
- •age of 18 years or older
- •good oral and general health
- •hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany).
排除标准
- •smoking, pregnancy or breastfeeding
- •previous dental whitening
- •para-functional habits
- •dentin sensitivity
- •anterior tooth with restorations and carious lesions
- •non-vital discoloration
- •unsatisfactory restorations
研究组 & 干预措施
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Selection and preparation of the volunteers (Procedure)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Evaluation of the tooth color (Procedure)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Relative isolation (Procedure)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Gingival protection barrier (Procedure)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Application of desensitizing gel (Procedure)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Hydrogen peroxide (Drug)
Group 1
The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
干预措施: Used a dentifrice (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Selection and preparation of the volunteers (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Evaluation of the tooth color (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Relative isolation (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Gingival protection barrier (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Application of desensitizing gel (Procedure)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Hydrogen peroxide (Drug)
Group 2
The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
干预措施: Used a dentifrice (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Selection and preparation of the volunteers (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Evaluation of the tooth color (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Relative isolation (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Gingival protection barrier (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Application of desensitizing gel (Procedure)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Hydrogen peroxide (Drug)
Group 3
The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
干预措施: Used a dentifrice (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Selection and preparation of the volunteers (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Evaluation of the tooth color (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Relative isolation (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Gingival protection barrier (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Application of desensitizing gel (Procedure)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Hydrogen peroxide (Drug)
Group 4
The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
干预措施: Used a dentifrice (Procedure)
结局指标
主要结局
The analysis of the reduction of sensitivity using the toothpaste during whitening.
时间窗: Through study completion up to 4 weeks placement of the tray.
For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
The evaluation of the tooth color using the toothpaste during whitening.
时间窗: Through study completion up to 4 weeks placement of the tray.
For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.
次要结局
未报告次要终点
研究者
Josué Junior Araujo Pierote
Principal Investigator
University of Campinas, Brazil