Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- The US Public Health Service criteria for marginal discoloration on restorations
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth
详细描述
Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)
The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
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
- None
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parents of the patients who accept to participate and sign the informed consent.
- •Patients who have at least four first and/or second primary molars that require class I restorations
- •Teeth that have healthy lamina dura and periodontal ligament
- •Teeth that have caries lesions not extending to the pulp radiographically
- •Patients whose first molar teeth are in occlusion
排除标准
- •Patients and parents of the patients who does not accept to participate and sign the informed consent
- •Teeth which need endodontic treatment
- •Teeth that have caries more than one surface
- •Teeth that are previously restored
- •Patients who are not cooperative for the dental procedure
- •Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
- •Patients who have bruxism, skeletal or dental malocclusion
- •Teeth that have developmental defects/anomalies or discoloration
- •Patients who have allergies to resin based restorative materials
结局指标
主要结局
The US Public Health Service criteria for marginal discoloration on restorations
时间窗: 2 years
Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction
The US Public Health Service criteria for marginal adaptation on restorations
时间窗: 2 years
Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin
The US Public Health Service criteria for anatomical form on restorations
时间窗: 2 years
A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement
The US Public Health Service criteria for secondary caries on restorations
时间窗: 2 years
A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries
The US Public Health Service criteria for retention of restorations
时间窗: 2 years
Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration
The US Public Health Service criteria for surface roughness on restorations
时间窗: 2 years
Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked
次要结局
未报告次要终点
研究者
Zafer Cavit Cehreli, DDS, PhD
Principal Investigator
Hacettepe University