Comparative Evaluation of Glass Ionomer and Resin-Based Fissure Sealants on Newly Erupted Permanent First Molars: A 24-Month Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Sealant retention
研究概览
简要总结
This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. The study evaluates which material provides better retention, marginal adaptation, and protection against dental caries over a 24-month period.
详细描述
This randomized, split-mouth, clinical study was designed to compare the clinical effectiveness of two different fissure sealant materials-glass ionomer-based (Fuji Triage™ Capsule) and moisture-tolerant resin-based (UltraSeal XT® Hydro)-in newly erupted permanent first molars in children aged 6-7 years.
The study evaluates the retention rates, marginal adaptation, marginal discoloration, and the ability of each material to prevent dental caries over a 24-month follow-up period. A total of 70 teeth from 35 children were sealed using a split-mouth design, ensuring that each participant received both types of sealants on contralateral molars. Clinical evaluations were performed at 1, 6, 12, 18, and 24 months using modified United States Public Health Service (USPHS) criteria.
The goal of the study is to determine whether the moisture-tolerant resin-based material offers a clinical advantage in terms of sealant retention and caries prevention in a partially erupted, moisture-challenged clinical environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-7 years
- •Children who are systemically healthy and classified as ASA I and II16
- •Children whose parents and themselves have agreed to attend the study and follow-up visits throughout the study period
- •Children who have established oral hygiene habits
排除标准
- •Children whose caregivers did not sign the informed consent form, and patients who wished to withdraw or for whom the treatment protocol was not properly followed.
- •Children who have restorations, cavitated surfaces or developmental defects and hypoplasia on the permanent first molar teeth to be treated.
- •Medically compromised and children who need special treatment.
- •History of adverse reactions to any restorative materials.
结局指标
主要结局
Sealant retention
时间窗: 1, 6, 12, 18, and 24 months
Assessment of the retention of the fissure sealant material on the occlusal surface of the first permanent molars using modified USPHS criteria. Evaluated at 1, 6, 12, 18, and 24 months.
次要结局
- Marginal adaptation(1, 6, 12, 18, and 24 months)
- Marginal discoloration(1, 6, 12, 18, and 24 months)
- Presence of caries(1, 6, 12, 18, and 24 months)
研究者
Gulcin Bulut
Associate Professor, DDS, PhD
Dokuz Eylul University