Comparative evaluation of the clinical performance of an Alkasite restorative material and Bulk fill composite for class II restoration in primary molars - A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical success rate of Alkasite and Bulk fill composite restorative material in pediatric dentistry interms of esthetic, functional and biological properties.
研究概览
简要总结
The study aims to evaluate the clinical performance of an Alkasite restorative material and compare it with Bulk fill composite in class II restorations in primary molars. The result obtained from this study may help clinician to choose appropriate restorative material for class II cavities in primary molars and may lead to improved clinical outcomes.
It is an Academic Randomized Clinical Trial, an Interventional study.A total of 26 patients aged 4-9 years with occluso-proximal carious lesions on primary maxillary or mandibular molars will be selected from the OPD of Department of Pediatric and Preventive Dentistry, Yenepoya Dental College. This study will be conducted after obtaining the institutional ethics committee clearance in the Department of Pediatric and Preventive Dentistry. Parents will be given a brief introduction explaining the procedure. Informed written consent will be obtained from parents of the selected participant. Restorative treatment of Class II Caries will be done using Cention Forte (Group A) on one side and Tetric N Ceram (Group B) on other side. Esthetic, functional and biological properties will be assessed using FDI Criteria at baseline and thereafter at 3, 6, 9, and 12 months, respectively.The above results will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 4-9 years presenting with proximal carious lesions on primary maxillary or mandibular molars on either side (bilateral) of the arch.
- •Presence of two class II carious lesions on maxillary or mandibular primary molars, with no signs of pulpitis or necrosis bilaterally.
- •The ICDAS score of the caries has to be lower than 5 (visible dentin in a distinct cavity) and the caries score of 2.1-2.2 according to the Graham J Mount classification.
- •Cavities with buccolingual width that involved less than 2/3 of the intercuspal distance or required cusp coverage.
排除标准
- •Behaviorally uncooperative children Children with special health care needs with intellectual disabilities Children with parafunctional habits like bruxism Teeth with proximal cavities that involved more than two surfaces Children with habitual chewing on unilateral side Inadvertent pulp exposure during cavity preparation Lack of gingival seat area.
结局指标
主要结局
Clinical success rate of Alkasite and Bulk fill composite restorative material in pediatric dentistry interms of esthetic, functional and biological properties.
时间窗: one year
次要结局
- Clinical success rate of Alkasite restoration compared it with Bulk fill composite restoration.(one year)
研究者
Dr Aisha Yenepoya
Yenepoya Dental College