A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
研究概览
简要总结
This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.
详细描述
Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.
The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.
Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.
The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.
Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One proximal lesion in a primary molar.
- •Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
- •Proximal contact with adjacent healthy or restored teeth.
- •Occlusal contact with opposing healthy or restored teeth.
- •No indication for pulp therapy or other restorative treatment.
- •A predicted survival until exfoliation of 2 years.
排除标准
- •Radiographic evidence of caries extending into the inner half of dentin.
- •No proximal contact with adjacent healthy or restored teeth.
- •No occlusal contact with opposing healthy or restored teeth.
- •Tooth indicated for pulp therapy or other restorative treatment.
- •A predicted survival until exfoliation of less than 2 years.
结局指标
主要结局
clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
时间窗: 2 Years
the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
次要结局
未报告次要终点
研究者
Sumaya Nouri
BDS, M.Sc
King Abdulaziz University