Efficacy of CPP-ACP on Bleaching Related Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in sensitivity measures related to bleaching: Subjective Sensitivity
研究概览
简要总结
Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching.
Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Group 1 bleached Maxillary arch, Group 2 bleached mandibular arch. Two weeks later subjects stopped bleaching the first arch and started second arch. Sensitivity was measured by VAS daily log scale for two weeks. Shade was taken with colorimeter and Classic Vita shade guide at baseline, immediate post-bleaching, and two weeks post-bleaching. Longitudinal sensitivity over the 14 days period of bleaching was summarized. The Wilcoxon Signed Rank test was used to compare summary measures.
详细描述
Study Design
This was a randomized, controlled, split-mouth cross-over design clinical trial. Subjects were randomized into two groups depending on the control and intervention arches:
- Group 1: The maxillary arch was the control arch (only bleaching) while the mandibular arch (MN) was intervention arch (bleaching and MI Paste).
- Group 2: The MN arch was the control arch (only bleaching) while the MX arch was the intervention arch (bleaching and MI Paste).
Ethical permission for the study was obtained from the University Intuitional Review Board (No. 200604706). The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines. Informed consents were obtained from the subjects prior to enrolment in the study.
Participants Forty-six participants were recruited at the Oral Health Center. Participants were included if they age between 18 and 55 years old with no prior history of bleaching, not using any desensitizing agents, and with anterior teeth of shade A2 or higher. Participants allergic to milk protein, pregnant, and/or on daily NSAIDs were excluded. They were also excluded if they have had an anterior crown or composite restoration, scaling or periodontal surgery performed in the past six months, and/or had a history of bleaching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
- •Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
- •Subjects who were available for a potential recall period of one year.
- •Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.
排除标准
- •Subjects who had any known allergies to any materials used in this protocol.
- •Patients with milk protein allergies since one of the materials used is derived from milk protein.
- •Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
- •Subjects involved in other clinical trials utilizing a similar protocol.
- •Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
- •The subjects who have used any desensitizing agents including toothpaste in the past six months.
- •Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
- •Subjects who had any periodontal surgery or scaling performed in the past six months.
结局指标
主要结局
Change in sensitivity measures related to bleaching: Subjective Sensitivity
时间窗: 28 DAYS
Thermal Sensitivity: Subjective Measure: Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain". Subjects were asked to pick a number. 2\. Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
Change in sensitivity measures related to bleaching: Objective Sensitivity
时间窗: 28 days
Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.
次要结局
- Shade change and interference of CPP-ACP with bleaching(14 days)
研究者
Shaista Rashid
Assistant Clinical Professor
University of New England