Clinical performance of preformed CAD CAM milled PMMA crown and stainless steel crown for primary molar teeth using dental operating microscope
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical success rate
研究概览
简要总结
The proposed study will investigate the clinical performance and gingival health of preformed CAD/CAM milled polymethyl methacrylate (PMMA) crowns in comparison to stainless steel crowns (SSCs) for the restoration of primary molars with extensive multi-surface carious lesions. Given the growing emphasis on aesthetics in pediatric dentistry, SSCs, despite their long-standing use, face criticism due to their metallic appearance. Therefore, this randomized clinical trial aims to explore the viability of PMMA crowns as an aesthetic alternative while evaluating their clinical success and impact on gingival health.
The study will be conducted in a hospital-based setting, with primary molars undergoing pulpal treatment before restoration with either SSCs or PMMA crowns. Clinical and radiographic assessments will be performed at multiple follow-up intervals to evaluate parameters such as gingival health, plaque accumulation, crown retention, and potential complications. A non-parametric statistical approach will be utilized to analyze the collected data.
The expected outcome of this study is to provide insights into the potential advantages and limitations of PMMA crowns in comparison to SSCs, particularly in terms of aesthetics, clinical longevity, and biocompatibility. If found to be clinically effective and safe, PMMA crowns could serve as a promising aesthetic alternative to traditional SSCs for pediatric dental rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 4 to 10 years Children requiring crown for the maxillary/ mandibular second primary molar.
- •Children with teeth expected to remain in place for over 2 years before exfoliation Children with teeth that are pulpally treated Children with caries affecting multiple surfaces, and stable occlusion.
排除标准
- •Children with
- •Disabilities and systemic diseases,
- •Frankl behavior classification scale rating of negative or definitely negative,
- •TMJ disorders
- •Oral habits such as bruxism.
结局指标
主要结局
Clinical success rate
时间窗: assessment of | 1. survival rate | 2. clinical signs of pathology including swelling and pain | 3. Gum health in terms of gingival index are all assessed at baseline, 1 week , 3 months and 6 months interval
次要结局
- Measurement of occlusal wear(Measurement of occlusal wear is done using intra oral scanner at baseline, 1 week , 3 months and 6 months interval)
研究者
Dr A K Shanmugaavel
Chettinad Dental College and Research Institute