Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 主要终点
- Tooth Sensitivity (TS)
研究概览
简要总结
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
详细描述
This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .
After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Upper and lower anterior teeth without restorations;
- •Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
排除标准
- •Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
- •Presence of non-carious lesions, such as abfraction, erosion and abrasion;
- •Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
- •Use of fixed orthodontic appliances;
- •Presence of tooth sensitivity classified as equal to or greater than mild;
- •Presence of severe dental dimming;
- •Presence of parafunctional habits;
- •Presence of any oral pathology;
- •pregnant and lactating women
研究组 & 干预措施
Combined Bleaching(2x20)
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
干预措施: Combined Bleaching(2x20) (Procedure)
Combined Bleaching(2x20) with arginine
Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
干预措施: Combined Bleaching(2x20) with arginine (Procedure)
Combined Bleaching(2x20) with arginine
Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
干预措施: 8% arginine and calcium carbonate (Drug)
Combined Bleaching(1x20)
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
干预措施: Combined Bleaching (1x20) (Procedure)
Combined Bleaching(1x20) with arginine
Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
干预措施: Combined Bleaching(1x20) with arginine (Procedure)
Combined Bleaching(1x20) with arginine
Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
干预措施: 8% arginine and calcium carbonate (Drug)
结局指标
主要结局
Tooth Sensitivity (TS)
时间窗: during bleaching, and up to 48 hours postbleaching
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)). Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
次要结局
- Color Evaluation(The evaluations were performed in the baseline period and one month after the treatment)
研究者
Terezinha de Jesus Esteves Barata
tde Jesus Esteves Barata
Universidade Federal de Goias