Prevention of Enamel Demineralization in Fixed Appliance Orthodontic Patients Using CPP-ACP-NaF Varnish Compared to Blank Varnish Base. A Randomized Split Mouth Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Demineralization
研究概览
简要总结
Sometimes when people wear braces, the combination of dental plaque and diets high in sugar and acids can lead to white spots on the teeth surrounding the braces. These are commonly found in people with braces depending on their diet and care of their teeth. The white spots will still be present when the braces are removed. These white spots are the beginning signs of cavities and show that mineral has been lost from the tooth. This study will be testing a new varnish that is painted on the tooth around the braces to prevent these white spots from forming.
This study will enroll patients who wear braces and have planned teeth extractions. A calcium and fluoride releasing varnish will be painted on the teeth planned to be extracted. Braces will then be placed on the teeth. In 3-6 weeks, the extraction will occur and the teeth will be collected for analysis.
详细描述
This is a randomized split mouth double blinded clinical trial. The CPP-ACP-NaF varnish is commercially available and is used for the treatment of tooth hypersensitivity under FDA 510K K102808. The placebo for this study is the same product without the CPP-ACP-NaF component. Patients with planned orthodontic therapy that include tooth extractions will have orthodontic brackets attached to the to-be-extracted teeth. Each patient will have the CPP-ACP-NaF varnish and the varnish base (without CPP-ACP-NaF) applied to teeth immediately after orthodontic brackets have been applied. The specific teeth (left or right) will be randomly determined as to the application of the varnish or placebo. In this experimental design each patient has CPP-ACP-NaF applied to one side and placebo applied to the other side.
When the teeth are extracted they are transferred to the Carey Laboratory for in vitro evaluations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The placebo and the CPP-ACP-NaF varnishes will be supplied by the manufacturer labeled as either A or B. The blinding code is provided in a sealed envelop should there be a need to unblind the experiments.
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient at the University of Colorado School of Dental Medicine Department of Orthodontics who agree to consent to this study.
- •Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches.
- •Orthodontic treatment plans that include extractions of at least 3 bicuspids for orthodontic therapy
- •At least 10 years of age
- •The patient has adequate oral hygiene
排除标准
- •Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment
- •Younger than 10 years of age
- •Allergies to cow's milk or cow's milk products
- •Any condition that contraindicates orthodontic treatment, or are not willing to consent to the study.
研究组 & 干预措施
CPP-ACP-NaF
Dental varnish that contains calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket.
干预措施: CPP-ACP-NaF varnish (Device)
Placebo
Dental varnish base that does not contain calcium phosphoprotein stabilized amorphous calcium phosphate and sodium fluoride (CPP-ACP-NaF) is applied to the teeth with orthodontic brackets on one side of the mouth immediately after the teeth have received the bracket.
干预措施: CPP-ACP-NaF varnish (Device)
结局指标
主要结局
Demineralization
时间窗: Up to 14 days after teeth extractions
mineral density as determined by micro computed tomography (uCT)
Caries location
时间窗: Up to14 days after teeth extractions
Canary number that indicates early demineralization determined by the Canary System for caries identification
次要结局
未报告次要终点