A randomized controlled trial to evaluate clinical performance of pre-formed zirconia crowns, CAD/CAM zirconia crowns and pre-formed resin polymer crowns in primary molars post endodontic therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Crown Retention – Assessment of crown stability and dislodgement.
研究概览
简要总结
The Pre-formed polymer crowns are new to Indian market and can change scenario of pediatric dentistry as they are formed by high strength resin polymer used in the medical device industry in applications requiring high strength, flexibility and durability and cost effective. Bis-GMA is absent in these crowns. Bis-GMA contains Bisphenol A which is linked to have harmful effect on brain and increase risk of cardiovascular disease. No BisGMA in it makes them safe for the growing child’s mental health.
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
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy children Age range 5-10 years old Co-operative child Endodontic treated primary mandibular molars.
排除标准
- •More than 1/3 of root resorption is present Presence of abscess in primary mandibular molars indicated for extraction Presence of mobility in primary mandibular molars No Parental consent Tooth with pre-shedding and abnormal pathological mobility.
结局指标
主要结局
Crown Retention – Assessment of crown stability and dislodgement.
时间窗: Crown Retention – Assessment of crown stability and dislodgement. | Marginal Integrity – Evaluation of crown fit and marginal adaptation. | Gingival Health – Monitoring of gingival response around crowns. | Color Stability – Assessment of discoloration or staining over time.
Marginal Integrity – Evaluation of crown fit and marginal adaptation.
时间窗: Crown Retention – Assessment of crown stability and dislodgement. | Marginal Integrity – Evaluation of crown fit and marginal adaptation. | Gingival Health – Monitoring of gingival response around crowns. | Color Stability – Assessment of discoloration or staining over time.
Gingival Health – Monitoring of gingival response around crowns.
时间窗: Crown Retention – Assessment of crown stability and dislodgement. | Marginal Integrity – Evaluation of crown fit and marginal adaptation. | Gingival Health – Monitoring of gingival response around crowns. | Color Stability – Assessment of discoloration or staining over time.
Color Stability – Assessment of discoloration or staining over time.
时间窗: Crown Retention – Assessment of crown stability and dislodgement. | Marginal Integrity – Evaluation of crown fit and marginal adaptation. | Gingival Health – Monitoring of gingival response around crowns. | Color Stability – Assessment of discoloration or staining over time.
次要结局
未报告次要终点
研究者
Dr Nidhi Gupta
Santosh Dental College and hospital, Ghaziabad