Clinical and radiographic evaluation of preformed Bioflx â„¢ and stainless steel crowns on vital primary molars : A randomized controlled trial.
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Dr DY Patil Deemed to be University School of Dentistry
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The proximal contact, marginal extension, occlusion, indentations on crown, retention of crown, staining of crown, gingival index, plaque index, and parental acceptability for both SSC and Bioflx crowns will be evaluated as primary outcomes
概览
简要总结
· The study will involve 30 carious primary molars with wide proximal and multisurface caries requiring full coverage crowns in children aged three to nine years, randomly allocated to, group 1: Bioflx™ crowns and group 2: Stainless steel crowns. Following the protocol of tooth preparation and crown placement, the clinical and radiographic evaluation will be performed immediately after crown placement, after 1 week, 1 month, 3 months, 6 months. The clinical evaluation will comprise of assessing the proximal contact, marginal extension, occlusion, indentations on crown, tooth wear in opposing arch, retention of crown, staining of crown, gingival index, plaque index, and parental acceptability immediately and at 6 months follow up. The radiographic assessment will include crown evaluation and marginal adaption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •a) 3-9 year old under the ASA class 1 b) Primary molars with multisurface caries or wide proximal caries without clinical and radiographic signs of pulp pathology c) Primary molars without pathological root resorption d) Frankl’s rating score of positive or definitely positive e) Presence of antagonist tooth.
排除标准
- •a) Children whose parents did not give consent for participation in the study b) Children with systemic illness OR on medicines that may alter the gingival health c) Physiological root resorption of more than one-third of root length d) Habit of bruxism.
结局指标
主要结局
The proximal contact, marginal extension, occlusion, indentations on crown, retention of crown, staining of crown, gingival index, plaque index, and parental acceptability for both SSC and Bioflx crowns will be evaluated as primary outcomes
时间窗: The time points at which the evaluation will be done are 1 week, 1 month, 3 months and 6 months
次要结局
- The tooth wear in the opposing arch will be evaluated as secondary outcome measure.(The evaluation will be done at 1 week, 1 month, 3 months & 6 months of follow up)
研究者
Dr Ashveeta Shetty
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai.