Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Retention of sealant
研究概览
简要总结
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
详细描述
New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.
With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
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)
盲法说明
Blinding to participants : will not know either the intervention or the comparator will be applied to their teeth Blinding to investigator: covering the 2 syringes with opaque seal to avoid performance bias Blinding to outcomes assessor: to overcome detection bias
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria of participants:
- •Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
- •Co-operative patients approving to part- icipate in the trial.
- •Good oral hygiene.
- •Inclusion Criteria of teeth:
- •Caries susceptible occlusal pits and fissures.
- •Intact contact with opposing teeth.
- •Teeth with no previous restorations in other surfaces.
排除标准
- •Exclusion criteria of participants:
- •patients with Disabilities, systemic disease or severe medical complications.
- •patients have allergic history concerning methacrylate.
- •patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
- •participants who show lack of compliance.
- •Exclusion criteria of teeth:
- •Carious pits and fissures.
- •Developmental tooth defect.
- •Partially erupted teeth
- •Periapical pathology or signs of pulpal pathology.
- •Tooth hypersensitivity.
- •Heavy occlusion and occlusal contacts.
结局指标
主要结局
Retention of sealant
时间窗: 1 year
rate of sealant loss
次要结局
- Caries incidence(1 year)
研究者
Samaa Salah Eldin Abd Elfattah
Assistant lecturer in pediatric dentistry department, faculty of Dentistry
Cairo University