Clinical Evaluation of Enamel Microhardness Using At-Home and In-Office Tooth Whitening Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Is there loss of enamel hardness using two different concentrations of Hydrogen Peroxide
研究概览
简要总结
The examiner will review the medical history taken by your orthodontist that determined your eligibility to participate in this study on the first appointment. If the examiner determines that the position and condition of your teeth meet the inclusion and exclusion criteria for participation in this study, we will enroll you to participate in the study. Once accepted, a small area (1 mm) of the premolars will be flattened and polished. Next, your upper teeth will be scanned to make an impression, and the bleaching tray will be made on it. None of these procedures are painful, nor do they require anesthesia. This first appointment will last about 60 minutes. At the second appointment, the initial color of the upper premolar to be bleached will be taken. You will also be given a personalized whitening tray, a container to store the tray when not in use, a tube of low-concentration teeth whitening agent, and a toothbrush and toothpaste. The examiner will show you how to place the tray on the upper arch. You will wear it through the night for fourteen nights. You will be given a chart for you to mark every night when you put the tray in your mouth and brush your teeth. She will call you the next day and in 7 days to see if you have had any problems putting the gel in the tray and using it. This appointment will last approximately 30 minutes. The third appointment will consist of the examiner isolating one of the lower premolars that will be extracted. Some gel will be applied to that tooth three times; each time, the gel will stay on your tooth for 20 minutes. If the soft tissue or tooth is sensitive, a soothing gel will be applied to relieve the discomfort. This appointment will last approximately 90 minutes. The fourth appointment will be 14 days after the at-home bleaching was done and the in-office bleaching was accomplished. During this appointment, a lower premolar might be etched for 15 seconds. At this appointment, the oral surgeon your orthodontist recommends will extract your teeth. That will be the final appointment. During these 14 days, you must keep cleaning your teeth every day at least twice a day.
详细描述
14- PROJECT METHODOLOGY: Methods and materials This study consists of 40 patients requiring the extraction of four permanent first or second premolars for orthodontic reasons. Patients will be recruited from the Universidad Intercontinental (UIC) Graduate Program in Orthodontics, and private orthodontist dental offices in the city of Mexico. Patients who identify as needing extraction of the four first or second permanent premolars and who meet the following inclusion criteria will be invited to participate in the study.
Inclusion criteria:
- Have the four premolars in different quadrants that their orthodontist recommends be extracted.
- The premolars to be extracted should have prominent facial surfaces.
- Willing to have the four premolars slightly flattened and smoothed.
- Willing to have all four premolars extracted for orthodontic reasons.
- Between 12 and 35 years of age.
- Willing to attend four appointments.
- Willing to wear a custom-made whitening tray during the evening when they sleep.
- Willing to have their premolars bleached with In-Office and At-Home bleaching agents and one of their teeth that will be extracted treated with phosphoric acid.
- Willing to sign a consent form (parents must co-sign if they are under 18).
- Willing to discontinue active orthodontic treatment during whitening treatment.
- Willing to brush at least twice a day with fluoridated toothpaste provided during the study.
Exclusion criteria:
- Restorations or visible cavities in any tooth to be extracted.
- The presence of visible intraoral structural defects or pathology.
- Use of over-the-counter or professionally prescribed whitening agents in the past six months.
- Teeth with tetracycline staining.
- History of any medical illness that may interfere with the study or require special considerations.
- Pregnant or lactating women.
- Not willing to do the blood tests (biometrics hematic, prothrombin, and thromboplastin) prior to extractions (a legal requirement of the Oral Surgery Department of the UIC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have the four premolars in different quadrants that their orthodontist recommends be extracted.
- •The premolars to be extracted should have prominent facial surfaces.
- •Willing to have the four premolars slightly flattened and smoothed.
- •Willing to have all four premolars extracted for orthodontic reasons.
- •Between 12 and 35 years of age.
- •Willing to attend four appointments.
- •Willing to wear a custom-made whitening tray during the evening when they sleep.
- •Willing to have their premolars bleached with In-Office and At-Home bleaching agents and one of their teeth that will be extracted treated with phosphoric acid.
- •Willing to sign a consent form (parents must co-sign if they are under 18).
- •Willing to discontinue active orthodontic treatment during whitening treatment.
- •Willing to brush at least twice a day with fluoridated toothpaste provided during the study.
排除标准
- •Restorations or visible cavities in any tooth to be extracted.
- •The presence of visible intraoral structural defects or pathology.
- •Use of over-the-counter or professionally prescribed whitening agents in the past six months.
- •Teeth with tetracycline staining.
- •History of any medical illness that may interfere with the study or require special considerations.
- •Pregnant or lactating women.
- •Not willing to do the blood tests (biometrics hematic, prothrombin, and thromboplastin) prior to extractions (a legal requirement of the Oral Surgery Department of the UIC).
结局指标
主要结局
Is there loss of enamel hardness using two different concentrations of Hydrogen Peroxide
时间窗: one month
Measure hardness with Vickers Hardness tester
Differences in enamel microhardness
时间窗: From enrollment to end of one month
Measure loss of microhardness when using different concentrations of HP
时间窗: 14 days for 3% and immediately for 40% HP
Use Vickers Hardness Tester
次要结局
未报告次要终点