Retention and Caries-Preventive Outcomes of Glass Ionomer-Based Fissure Sealants in Children: A 24-Month Split-Mouth Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- retention rates of fissure sealants
研究概览
简要总结
This study aimed to comparatively evaluate the 24-month clinical retention performance and caries-preventive efficacy of three glass ionomer-based fissure sealants with different compositions.
详细描述
This study aimed to comparatively evaluate the 24-month clinical retention performance and caries-preventive efficacy of three glass ionomer-based fissure sealants with different compositions.
This randomized, controlled, double-blind, split-mouth clinical trial was conducted with approval from the Medhical Ethics Committee of İzmir Kâtip Çelebi University (14/100) and registered at ClinicalTrials.gov (NCT07110701). The study included 200 healthy children (ASA I), aged 6-12 years, with moderate caries risk. A total of 400 sealants were applied to the two fully erupted mandibular first molars of each participant. Following randomization, one molar received GC Fuji Triage (high-fluoride containing/control), while the contralateral molar received either GC Fuji VII EP (CPP-ACP-containing) or GCP Glass Seal (nano-fluorohydroxyapatite-containing). Applications were performed by a single clinician in accordance with manufacturers' instructions. Patients were evaluated at 3-, 6-, 12-, 18-, and 24-months. Retention, marginal integrity, marginal discoloration, and secondary caries were assessed using modified USPHS criteria. Occlusal caries progression was monitored via ICDAS-II codes and DIAGNOdent measurements
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)
盲法说明
The study was carried out as a double-blinded trial, whereby neither the patients nor the clinical evaluator was aware of what material was applied to each tooth. No blinding was done during the treatment period because all treatments were performed by one dentist. The randomization process was applied with two phases to ensure unbiased allocation of the fissure sealant materials to the participants. In the first phase of the randomization, which material groups (GC Fuji Triage -GCP Glass Seal/GC Fuji Triage-GC Fuji VII EP) would be applied to each patient was determined using a computer-generated randomization online tool (htpp//randomizer.org). In the second phase of the randomization, the allocation of the material to either the left or right mandibular molar of each participant was established through the coin toss method (heads or tails), and the opposing molar tooth was treated with the other material in accordance with the group designated by the first randomization.
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 200 healthy children aged between 6 and 12 years, ASA class I (American Society of Anesthesiologists),
- •27 who were determined to exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
- •All participants had fully erupted lower first permanent molars on both sides which required the application of pit and fissure sealants.
- •The inclusion criteria were based on the International Caries Detection and Assessment System II (ICDAS II) criteria,28 including deep and retained pits and fissures, no restorations, and no evidence of caries lesions.
- •The teeth were examined using the caries diagnosis device (DIAGNOdent pen 2190, KaVo, USA); readings of ≤ 15 were included in the study as well.
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.
- •A bitewing radiograph was used to assess teeth suspected of having caries on their proximal surfaces, and those with caries were excluded from the study.
研究组 & 干预措施
CPP-ACP-containing fissure sealant
In this group, one mandibular molar was treated with a high-fluoride glass ionomer-based fissure sealant (Fuji Triage, GC Corporation, Tokyo, Japan; control group), while the contralateral molar was treated with a CPP-ACP-containing fissure sealant (Fuji VII EP, GC Corporation, Tokyo, Japan)
干预措施: Retention of Fissure Sealants (Other)
Nano-fluorohydroxyapatite-containing fissure sealant
In this group, one mandibular molar was treated with a high-fluoride glass ionomer-based fissure sealant (Fuji Triage, GC Corporation, Tokyo, Japan; control group), while the contralateral molar was treated with nano-fluorohydroxyapatite-containing fissure sealant (GCP Glass Seal, GCP Dental, Vianen, The Netherlands)
干预措施: Retention of Fissure Sealants (Other)
结局指标
主要结局
retention rates of fissure sealants
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-, 18-, and 24 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