Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Development of new caries lesion
研究概览
简要总结
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For children:
- •Children presenting with good general health and cooperative behavior.
- •Children having early caries lesions in a permanent molar (first or second).
- •Parents signed informed consent.
- •For permanent molars:
- •Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and
- •[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8].
- •Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). [Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9].
排除标准
- •For children:
- •Any allergy reported by the parents.
- •Children unable to return for recall visits.
- •For permanent molars:
- •Teeth with occlusal surfaces completely covered by the gingival tissue.
- •Teeth with hypoplastic defects, restorations, or sealants.
研究组 & 干预措施
Fluoride varnish group
5% sodium fluoride varnish, 3M, USA
干预措施: Fluoride varnish (Drug)
Self-etch sealant group
Self-etch primed sealant, Shofu, Japan
干预措施: Self-etch sealant (Drug)
Conventional etch and rinse sealant group
Resin-based composite sealant, 3M, USA
干预措施: Conventional etch and rinse sealant (Drug)
结局指标
主要结局
Development of new caries lesion
时间窗: 12 months
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
次要结局
- Sealants retention(12 months)
- Quality of sealants(12 months)
研究者
Le Van Nhat Thang
DDS, PhD, Principal Investigator
Hue University of Medicine and Pharmacy