Effect of Arginine and Nano-hydroxyapatite Solutions on Hypersensitivity and Color Changes of Bleached Enamel: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Teeth Hypersensitivity change
研究概览
简要总结
The aim of this in vivo study is to evaluate the post-bleaching enamel hypersensitivity and the possible color changes following the application of arginine and nano-hydroxyapatite remineralizing solutions after enamel bleaching using an in-office chemical bleaching agent. A commercial Fluoride remineralizing and desensitizing agent will be used as the control group. Following bleaching of the anterior teeth and then the application of the different tested remineralizing agents; the patients will be assessed for post-bleaching hypersensitivity using the visual analogue scale (VAS) to describe the severity of the hypersensitivity from mild to moderate to severe. On the other hand, the baseline shade and post-bleaching color changes will be evaluated using a shade guide. The data will be collected and tabulated then the statistical analysis will be performed.
The null hypothesis is that the different tested remineralizing agents will have a similar effect on the post-bleaching teeth hypersensitivity & the color changes of the bleached teeth.
详细描述
Recently, there has been several patients that favor the in-office bleaching technique due to its quick and satisfying aesthetic outcome, nevertheless clinical research reported some clinical adverse effects. Teeth hypersensitivity is the most common adverse effect of teeth bleaching. It was suggested that hydrogen peroxide can pass to the pulp through enamel and dentin to create an inflammatory reaction or directly stimulate the neural receptors triggering pain sensation.
It was reported that tooth sensitivity during bleaching has a range of 18-78%. Usually, teeth hypersensitivity subsides upon accomplishment of the bleaching procedure, but occasionally it may cause the patient to withdraw from form the treatment session. Different methods and approaches with a varying rate of success have been advocated to reduce teeth sensitivity, such as decreasing the rate of application, using different desensitizing agents before or after bleaching procedure, desensitizing agent incorporation into the bleaching gel, and decreasing the concentration of bleaching agent. In this context, the efficacy of desensitizing obliteration agents to prevent and treat the post-bleaching hypersensitivity has been investigated in many clinical trials presenting promising results. These obliterating agents can enhance the enamel mineral content, impeding hydrogen peroxide infiltration to the nerve endings and thereby hypersensitivity is much reduced or even eliminated.
Study design:
This randomized clinical study will use the "excel sheet" for randomization and assigning the subjects into the respective test groups.
All the included subjects will sign an informed consent before participating in this clinical study, in full accordance with the World Medical Association Declaration of Helsinki.
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 (Participant)
盲法说明
None of the participants is aware of the remineralizing agent to be applied to his/her teeth after bleaching
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants of 18-55 years old
- •Participants with good general and oral health.
- •Participants did not undergo any bleaching procedure before.
- •Participants with caries-free maxillary six anterior teeth without any restorations.
- •Participants do not suffer of periodontal diseases.
- •Participants willing to assess and sign the informed consent form.
排除标准
- •Participants with anterior restorations.
- •Participants with dental prosthesis of the anterior teeth.
- •Participants with orthodontics brackets.
- •Participants with severe internal teeth discoloration as in cases of tetracycline stains, fluorosis or non-vital teeth.
- •Smoking participants.
- •Breastfeeding and pregnant women.
- •Participants with gingival and bone recession.
- •Participants with dental erosion, dentin exposure, and cracked teeth or any other pathologic condition that may elicit teeth sensitivity.
- •Participants having their teeth bleached.
- •Participants taking analgesic or anti-inflammatory drugs.
- •Participants with bruxism habits are excluded from the study.
结局指标
主要结局
Teeth Hypersensitivity change
时间窗: Baseline to 3-week follow up period.
Evaluation of the change in the pre- and post-bleaching teeth hypersensitivity using the Visual Analogue Scale method (VAS) to describe the severity of the hypersensitivity from mild to moderate to severe. Whereby, readings from 0-10. Zero denoting no sensitivity, 1-3 is presented as mild, 4-7 is presented as moderate and 8-10 is presented as severe sensitivity by the description of each one of the participants using a printed chart.
次要结局
- Color change(Baseline to 3-week follow up period.)
