Evaluation of 1-year Survival Rates of Two Different Fissure Sealants Applied to Immature Permanent Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Modified Simonsen Criteria
研究概览
简要总结
Dental caries remains one of the most prevalent oral diseases today. The risk of caries development is highest during the first few years following tooth eruption. Therefore, preventive strategies for dental caries continue to be of great importance.
In particular, permanent second molars are highly susceptible to caries during their eruption phase, as the enamel has not yet completed its physiological maturation. This vulnerability is especially pronounced in partially erupted teeth, where the risk of caries formation increases significantly in the absence of effective preventive measures.
In this context, fissure sealants are widely used as a preventive approach, particularly in children and adolescents, due to their proven efficacy in caries prevention. In this study, the 12-month clinical performance of resin-based hydrophilic and glass ionomer-based fissure sealants applied to partially erupted permanent first and/or second molars will be evaluated comparatively.
Informed consent will be obtained from all participants prior to their inclusion in the study. The aim of this research is to provide scientific evidence to support material selection in the field of preventive dentistry.
Previous studies (Ahovuo-Saloranta et al., 2013) have emphasized that long-term clinical success rates have a direct impact on material selection, highlighting the importance of conducting prospective clinical trials.
This study is designed as a split-mouth, double-blind, randomized, controlled clinical trial. The reporting of the study will adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University.
Healthy children aged between 7 and 15 years will be included in the study. Randomization will be performed using a computer-assisted program. Two different fissure sealants will be applied to different teeth in each patient.
Application Procedure:
All fissure sealants will be applied by a single experienced operator in accordance with the manufacturer's instructions.
Resin-based sealants will be polymerized for 20 seconds using an LED light source.
Group A: Hydrophilic fissure sealant
Group B: Glass ionomer-based fissure sealant
Evaluation Time Points:
Immediately after application
At 3 months
At 6 months
At 12 months
The following parameters will be assessed by two independent blinded evaluators according to modified USPHS criteria:
Retention of the fissure sealant (Complete / Partial / Total loss)
Marginal discoloration
Development of secondary caries
Data will be entered into Microsoft Excel and analyzed using SPSS software. A p-value of < 0.05 will be considered statistically significant.
详细描述
This study is designed to compare the 12-month survival rates of GC Fuji Triage (glass ionomer-based) and UltraSeal XT™ hydro™ (Hydrophilic Pit and Fissure Sealant) fissure sealants applied to partially erupted permanent second molars. The research will be conducted using a split-mouth, double-blind, randomized, and controlled design, aiming to provide a high level of scientific reliability through its prospective nature.
Blinding of both participants and evaluators is intended to minimize observational bias and enhance the validity of the results. The study is expected to provide evidence-based data that will guide clinicians in material selection and contribute to the existing literature in the field.
Furthermore, by being reported in accordance with the CONSORT guidelines, the study will meet international standards for clinical research reporting.
Inclusion Criteria:
Healthy children aged 10 to 15 years. Partially erupted, caries-free or demineralized fissures with ICDAS scores 1-2 on permanent second molars, confirmed by clinical and radiographic examination.
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
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 10-15 years.
- •Partially erupted second permanent molars that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-
- •Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or
- •Oral Hygiene Index (OHI-S) score ≤ 3
- •Written informed consent obtained from the parent or legal guardian.
排除标准
- •Fully erupted or completely impacted teeth.
- •Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
- •History of systemic disease or long-term medication use.
- •Known allergy to resin-based or glass ionomer materials.
- •Presence of parafunctional habits.
研究组 & 干预措施
Gruop A:UltraSeal XT hydro sealant / hydrophillic pit and fissure sealent
The presence of moisture and saliva-contamination during the placement of the sealant compromise the quality of adhesion at the sealant-enamel interface, which impacts the ongoing resistance to microleakage of microorganisms. Hydrophilic sealants, which bond effectively to moist enamel surfaces, present a distinct advantage in paediatric dentistry where patient-compliance, isolation, and moisture-control can be particularly challenging.UltraSeal XT® hydro™ is a new moisture-tolerant, self-adhesive, light-cured, acrylate-based, hydrophilic pit, and fissure sealant which has been developed by Ultradent Products, USA. The sealant comprises a 53 wt% mixture of inorganic filler particles that confer radiopacity. This material is reported to "chase" moisture into the pits and fissures, thus eliminating moisture-related failure associated with hydrophobic sealants
干预措施: Preventive pit and fissure sealant application (Procedure)
Gruop B: GC Fuji Triage- glassionomer pit and fissure sealent
Glass ionomer (GI)-based fissure sealants are considered a valuable treatment alternative, particularly in pediatric dentistry for patients at high risk of caries, due to their ability to chemically bond to dental tissues, release fluoride, exhibit biocompatibility, provide antibacterial effects, and promote the remineralization of hydroxyapatite crystals. The self-bonding, high-fluoride-releasing GC Fuji TRIAGE® is frequently reported in the literature as a fissure sealant, particularly for immature and partially erupted teeth. The use of glass ionomers as fissure sealants is especially emphasized in cases where isolation is difficult.
干预措施: Preventive pit and fissure sealant application (Procedure)
结局指标
主要结局
Modified Simonsen Criteria
时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries
Edge Integrity Evaluation Criteria
时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment
0: The fissure sealant and tooth surface are intact and cannot be distinguished with a probe. 1. The edges of the fissure sealants can be distinguished with a probe. 2. There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa
Marginal Coloration Evaluation Criteria
时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment
0 No color change between fissure sealant and tooth. 1. Color change in only one area. 2. Color change in many areas. 3. Severe color change indicating leakage.
Anatomical Form Evaluation Criteria
时间窗: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.
0 Consistent with and continuous with occlusal form and structure. 1. Change in anatomical form but all pits and fissures covered. 2. a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant. 2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins
次要结局
未报告次要终点
研究者
Handan Vural
assistant professor
Inonu University