Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Sealant retention scoring using Color, Coverage and Caries (CCC) system
研究概览
简要总结
To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with good health and without any systematic diseases history which may interfere with their oral hygiene.
- •Children ranging in age from 6 to 9 years.
- •Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II).
- •Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
- •Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
- •No children will be excluded on the basis of gender, race, social or economic status
排除标准
- •Children with systemic diseases.
- •Children with oral habits affecting occlusion.
- •Children with any physical or mental disorders.
- •Children with cavitated, defected, missed or restored contralateral tooth.
- •Children with history of allergy to resin or latex.
- •Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects.
- •Not approving to sign the consent.
研究组 & 干预措施
Hydrophilic sealant
UltraSeal XT hydro™ sealant ®
干预措施: Hydrophilic fissure sealant (Other)
Hydrophobic sealant
Helioseal-F Sealant ®
干预措施: Hydrophobic fissure sealant (Other)
结局指标
主要结局
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 36 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 18 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 24 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 3 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 6 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
时间窗: At 12 months
次要结局
- Caries scoring using Color, Coverage and Caries (CCC) system(At 36 months)
- Caries scoring using Color, Coverage and Caries (CCC) system(At 3 months)
- Caries scoring using Color, Coverage and Caries (CCC) system(At 6 months)
- Caries scoring using Color, Coverage and Caries (CCC) system(At 12 months)
- Caries scoring using Color, Coverage and Caries (CCC) system(At 18 months)
- Caries scoring using Color, Coverage and Caries (CCC) system(At 24 months)
研究者
Hussein A. Alharthy
Postgraduate student
King Abdulaziz University