A Comparative Clinical Evaluation of Two Resin-Based Fissure Sealants Applied With Different Isolation Techniques: An 18-Month Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride)
研究概览
简要总结
The aim of this clinical study was to evaluate the effects of different isolation methods and material filler ratios on the retention rates of two different fluoride-containing fissure sealants over an 18-month period.
Methods:
A total of 100 children (200 teeth) participated in this randomized, single-blind, split-mouth clinical trial. The mandibular permanent first molars of each participant were divided into two groups: one receiving a highly filled fluoride-releasing fissure sealant (Fissurit FX, Voco, Germany), and the other an unfilled fluoride-releasing sealant (Teethmate F-1, Kuraray, Germany). Each material group was also divided into two subgroups based on the isolation method used: rubber dam or cotton roll isolation. Sealant retention rates were evaluated at 6-, 12-, and 18-month follow-up visits. Data were statistically analyzed using a 0.05 significance level.
详细描述
The aim of this randomized, controlled clinical trial was to assess (i) the retention rates of two different resin-based fissure sealant materials-one containing a high filler content and the other unfilled, both fluoride-releasing-and (ii) the effect of the isolation method (rubber dam versus cotton roll isolation) on sealant retention. Additionally, the study evaluated the effectiveness of these materials and isolation techniques in the prevention of dental caries. The null hypotheses tested were: (i) there is no significant difference in the retention rates between the two types of resin-based fissure sealants, and (ii) the type of isolation method employed does not significantly influence sealant retention.
Study Design:
This randomized, controlled, single-blind clinical trial was approved by the Medical Ethics Committee of Izmir Katip Celebi University (Approval No: 2025/059). Prior to the commencement of treatment, written informed consent was obtained from the parents or legal guardians of all participants. The study was conducted in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure the transparency and integrity of the methodology and results.
The study included 100 healthy children between the ages of 6 and 12 years (mean age: 7.9 years), all classified as ASA Class I (American Society of Anesthesiologists) and exhibiting cooperative behavior, as determined by a Frankl Behavior Rating Scale score of 3 or 4. All participants had fully erupted mandibular first permanent molars on both sides (totaling 200 teeth) requiring the application of pit-and-fissure sealants.
The clinical procedures were conducted by two trained investigators: one responsible for the baseline examination and treatment, and the other-blinded to the materials and methods used-responsible for follow-up assessments. Examiner calibration was performed at 20 randomly selected sites, and agreement was considered acceptable upon achieving substantial inter-examiner reliability (Cohen's Kappa ≥ 0.7).
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
- Single (Outcomes Assessor)
盲法说明
A split-mouth study design was implemented, in which two distinct fissure sealant materials were applied using two different isolation techniques. Each participant received both types of sealants-one placed under rubber dam isolation and the other under cotton roll isolation. To reduce the risk of allocation bias, the assignment of sealant materials and isolation methods to specific teeth was randomized. A computer-generated randomization list (Research Randomizer, Version 4.0) was used to determine both the order of sealant application and the side (right or left mandibular molar) to which each material would be assigned. Based on the combination of sealant type and isolation method, this process resulted in the creation of four distinct study groups.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study comprised 100 healthy children aged between 6 and 12 years
- •ASA class I (American Society of Anesthesiologists),
- •exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
- •All participants has to be fully erupted lower first permanent molars on both sides (200 teeth), which required the application of pit and fissure sealants.
- •The inclusion criteria is based on the International Caries Detection and Assessment System II (ICDAS II) criteria, including deep and retained pits and fissures, no restorations, and no evidence of caries lesions
排除标准
- •Participants with special needs or systemic disease (ASA classification II or higher),
- •requiring emergency dental care,
- •suffering from a severe gag reflex or an allergy to latex,
- •exhibiting uncooperative behavior (Frankl Score 1 or 2),
- •exhibiting molars with anomalies of the enamel/dentin, or
- •unable to attend follow-up appointments were excluded from the study.
结局指标
主要结局
The retention rates of two different resin-based fissure sealant materials (a pit and fissure sealant containing high-filler fluoride and a pit and fissure sealant containing non-filler fluoride)
时间窗: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, and 18-month follow-up visits.
Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
次要结局
未报告次要终点
研究者
Ebru KUCUKYİLMAZ
Prof. Dr.
Izmir Katip Celebi University