Clinical and Radiographic Assessment of Bioactive Restorative Material Versus Polyacid Modified Composite Resin in Treatment of Class II Restorations in Primary Molars: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Post-operative sensitivity
研究概览
简要总结
Successful restoration of cavities in primary molars can be considered challenging. It is different from restoring cavities in permanent molars because factors such as the level of co-operation of the child and the handling properties and setting time of the restorative material will have some influence on the success rate of the restoration. The ideal requirements that a filling material should possess include that it bears the occlusal force, withstands the acidic and bacterial attack, survives in the oral environment in addition to being biocompatible with the oral tissues.
In an attempt to achieve this idealism, a new class of restorative materials known as "bioactive materials" has been developed. The concept of bioactive materials was introduced in 1969 and later defined as "one that elicits a specific biological response at the interface of the material which results in the formation of a bond between tissues and the material." An example of bioactive materials is ACTIVA™ BioACTIVE (Pulpdent, USA). These materials are ionic composite resins which combine the biocompatibility, chemical bond and the ability to release fluoride of glass ionomers with the mechanical properties, esthetic and durability of composite resins.
Compomer is widely accepted as a standard restorative material for primary dentition for Class I and II cavities. Its range of success rate in Class II restorations in primary molars is 78-96%. Many randomized clinical trials have reported comparable clinical performance to composite resin with respect to color matching, marginal discoloration, anatomical form, marginal integrity and secondary caries. In comparison to glass ionomer and Resin Modified Glass Ionomer, compomers tend to have better physical properties in the primary dentition. However, their cariostatic properties didn't differ significantly from those materials.
详细描述
- Hypothesis:
The null hypothesis is that there is no difference between using ACTIVA and Dyract® in children to restore Class II cavities in carious vital primary second molars. 2. Trial design:
- A pilot study, parallel group, two arm.
- Allocation ratio is 1:1.
- Method
Intervention:
A) Diagnosis:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with Class II cavities in vital primary second molars.
- •Proximal enamel/dentin caries limited to outer half of dentin.
- •Age ranging from 4-8 years.
- •Good general health.
排除标准
- •Spontaneous pain related to carious molars.
- •Abscess or fistula on examination or during history taking.
- •Tooth mobility.
- •Radiographic evidence of root resorption or close shedding time.
- •Lack of patient co-operation.
结局指标
主要结局
Post-operative sensitivity
时间窗: 12 months
Using modified United States health service (USPHS)/ Ryge criteria. Scores: Alpha (A) = Ideal clinical restoration, Bravo (B) = acceptable clinical situation, and Charlie (C) = clinically unacceptable restorations (failure).
次要结局
- Marginal discoloration(12 months)
- Color match(12 months)
- Marginal adaptation (integrity)(12 months)
- Tooth fracture(12 months)
- Surface texture(12 months)
- Anatomic form(12 months)
- Gross/restoration fracture(12 months)
- Secondary caries(12 months)
- Pulpal affection(12 months)
研究者
Reem Mohsen Ahmed Moustafa
Assistant Lecturer
Cairo University