Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Retention of sealant
研究概览
简要总结
The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
详细描述
SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions.
With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral initial carious fissures in molars showing no signs of caries.
- •Co-operative patients approving to participate in the trial.
排除标准
- •Sound fissures.
- •Pregnancy.
- •Disabilities.
- •Systemic disease or severe medical complications.
- •Rampant caries.
- •Heavy smoking.
- •Xerostomia.
- •Lack of compliance.
- •Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
结局指标
主要结局
Retention of sealant
时间窗: 2 years
rate of sealant loss
次要结局
- Caries incidence(2 years)
研究者
Omar Osama Shaalan
Lecturer, Department of Conservative Dentistry
Cairo University