A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Sealant Retention Percentage at 12 Months After Treatment
研究概览
简要总结
The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.
详细描述
104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple:
Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients: American Society of Anesthesiologists (ASA) I or II
- •Good cooperation: Frank1 3 or 4
- •Aged between 6-16 years old at the day of sealant placement
- •Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.
排除标准
- •Teeth with a history of past or current caries
- •Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
- •Teeth with clinical or radiographic evidence of pathology
- •Teeth with a history of restoration or sealant
- •Patients who are poorly behaved
结局指标
主要结局
Sealant Retention Percentage at 12 Months After Treatment
时间窗: 12 months after treatment
Physical examination will be done in order to determine if there is a percentage difference in retention rate of teeth, specifically 12 months after treatment.
次要结局
未报告次要终点