An Evaluation of Protective Effects of OpalSeal™ Against Early Dental Decay in Orthodontic Patients. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Loss of Mineral Density in the Enamel
研究概览
简要总结
Fluoride is very effective in preventing dental decay (cavities) when applied in the form of a varnish on tooth surfaces. The purpose of this study is to verify if fluoride-releasing primer (OpalSeal) offers more protection against early dental decay (cavity) compared to conventional primer (Transbond XT) during treatment with braces.
详细描述
Primers are a type of 'glue' routinely used in orthodontics to attach brackets (metallic components) to the teeth. OpalSeal is a fluoride-releasing primer that has the potential to reduce cavities in patients receiving braces.
Orthodontic patients are at particular risk of developing two types of early carious lesions (decay):
- Around the brackets called White Spot Lesions and
- Along the sides of the teeth after slenderization procedure called inter-proximal reduction (IPR).
Our research questions are:
- Can OpalSeal offer protection against white spot lesions (WSL) around the brackets?
- Can OpalSeal offer protection against decay on the sides of teeth following IPR?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Opalseal and TransbondXT are identical in color, consistency and application allowing random assignments as well as patient blinding.
The outcomes assessor will also be blinded to the groups assignments.
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 10 and older seeking treatment at the VCU Orthodontics Clinic who require extraction of at least 2 teeth for orthodontic purposes
- •Such teeth should be free of any developmental defects
排除标准
- •Patients under 10 years of age
- •Patients with defective teeth
- •Those who cannot provide consent/assent OR not able to follow research protocols
- •Protected population (prisoners)
结局指标
主要结局
Loss of Mineral Density in the Enamel
时间窗: Time from initial bonding to extraction (max 90 days)
Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions
次要结局
- Surface Topography and Hardness(Time from initial bonding to extraction (max 90 days))
- Retention of OpalSeal(Time from initial bonding to extraction (max 90 days))