Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
研究概览
简要总结
The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.
详细描述
There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Children age group 3-7 yrs old
- •Primary molars affected with caries or hypoplastic defect.
- •Occlusion: Primary molar must have antagonist tooth.
- •Consent of parent (legal guardians) and child assent for 7 years.
- •Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
- •Status: Asymptomatic or symptomatic teeth with signs of reversible pulpitis
排除标准
- •Teeth with advanced stages of resorption (more than 2/3rd)
- •Teeth exhibiting irreversible pulpitis.
- •Teeth for which pulpotomy is done.
- •Molar in infraocclusion
- •Medically compromised children (ASA 3 or 4)
- •History of grinding or pathological attrition
- •Adverse gingival or periodontal conditions
结局指标
主要结局
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments
时间窗: 3, 6, 12, 18, 24 and 36 months
The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, gingival health, staining of crown, surface roughness of crown, opposing tooth, color match of crown, marginal fit, marginal discoloration, recurrent caries.
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments
时间窗: 3, 6, 12, 18, 24 and 36 months
The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes / no) of the findings for the following parameter separately: Widening of periodontal ligament space, furcation radiolucency, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.
次要结局
- Parental satisfaction(3, 12, 24 and 36 months)
- Child satisfaction(3, 12, 24 and 36 months)
- ECOHIS (Early Childhood Oral Health Impact Scale) survey(Pre-operative, 6, 12, 24 and 36 months)