"Comparative Clinical Evaluation of Microfilled Resin Sealant, Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children."
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To evaluate sealant retention
研究概览
简要总结
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups.
Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial.
Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group.
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows:
Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit.
OUTCOME MEASURES:
- Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
- Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
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
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MICROFILLED RESIN SEALANT
-Microfilled rein sealant (fissurit FX) after etching, washing, drying, sealant was gradually applied along the fissure of first permanent molar, Immediately light cured for 20 sec
干预措施: Sealant, Fissure (Drug)
NANOFILLED RESIN SEALANT
Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec.
干预措施: Sealant, Fissure (Drug)
FLOWABLE COMPOSITE
Flowable composite (Te-Econom Flow) after etching, washing, drying, adhesive was applied and dried under gentle air flow for 2-3 sec and was light cured. A uniform layer of flowable composite was applied and light cure for 20 sec.
干预措施: Sealant, Fissure (Drug)
UNFILLED RESIN SEALANT
Unfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure. Immediately light cure for 20 sec.
干预措施: Sealant, Fissure (Drug)
结局指标
主要结局
To evaluate sealant retention
时间窗: 9 months
Alpha - complete retention Bravo- partial retention Charlie- no retention
次要结局
- To evaluate marginal integrity(9 months)
- to evaluate anti caries effect(9 months)
- to evaluate colour change(9 months)
- to evaluate surface roughness(9 months)