The Effect of Single and Multiple Application of In-office Dental Bleaching on Tooth Sensitivity and Bleaching Efficacy: a Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tooth Sensitivity
研究概览
简要总结
The aim of this study is to evaluate the effect of single versus multiple application protocols for in-office dental bleaching using two different bleaching gels (Pola Office Plus, SDI, 37.5% HP and Opalescence Boost, Ultradent, 40% HP) on the risk and intensity of tooth sensitivity, as well as the effect of the application protocol on the bleaching efficacy.
Null hypothesis: There is no difference in intensity and risk of tooth sensitivity between single and multiple application of each gel and the application protocol dose not present significant effect on the bleaching efficacy.
详细描述
IV. Materials and Methods:
The study will be conducted in the post graduated Restorative dentistry clinics at Jordan University of science and technology. Ethical approval will be obtained from the JUST institutional ethics and human research board (IRB) committee. All the participants will be examined in a dental chair after dental prophylaxis with pumice and water to check whether they meet the study's eligibility criteria (Table 1).
Sample size estimation:
The primary outcome of this study is the absolute risk of tooth sensitivity. The absolute risk of tooth sensitivity was reported to be approximately 90% (21,22) for the in-office bleaching. Thus, a minimum sample size of 30 patients will be required in each group to have an 80% chance of detecting (with an alpha of 5%) a decrease in the primary outcome measure from 90% in the multiple application protocol to 45% in the single application group.
Experimental design:
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, Outcomes Assessor)
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
- •At least eight maxillary anterior teeth present.
- •Age over 18
- •The selected teeth have a mean shade of C2 or darker.
- •Good general and oral health. (no visible plaque or gingivitis)
- •No restorations or carious lesions on the buccal surfaces of the anterior teeth to be whitened
- •No history of tooth sensitivity
- •No use of a desensitizing agent or desensitizing toothpaste in the past six months
- •No use of pain killer for the last 48 hours
排除标准
- •Active caries and/or periodontal diseases (gingivitis and recession) or wasting diseases
- •Pregnant/lactating women.
- •Patients who have bleached their teeth previously.
- •No schedule availability
结局指标
主要结局
Tooth Sensitivity
时间窗: Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days and 7 days after bleaching.
Assessing reported tooth sensitivity by two scales.The VAS is a horizontal line with ten digits on it, ranging from 0 to 10, where 0 denotes no pain and 10 represents the worst possible suffering. The participants will be asked to identify their level of pain by marking the corresponding number. The NRS scale comprises scores to denote the intensity of pain (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = intense).
Tooth Sensitivity
时间窗: Assess sensitivity during the bleaching, 1 hour after bleaching, 1 day, 2 days and 7 days after bleaching.
Assessing reported tooth sensitivity by two scales.The VAS is a horizontal line with ten digits on it, ranging from 0 to 10, where 0 denotes no pain and 10 represents the worst possible suffering. The participants will be asked to identify their level of pain by marking the corresponding number. The NRS scale comprises scores to denote the intensity of pain (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = intense).
次要结局
- Change in teeth color(Shade will be recorded at base line before the bleaching procedure, seven days later, and 30 days after the end of the bleaching treatment.)
- Change in teeth color(Shade will be recorded at base line before the bleaching procedure, seven days later, and 30 days after the end of the bleaching treatment.)
研究者
Ghada Maghaireh
Principal Investigator
King Abdullah University Hospital