CTRI/2024/03/063696尚未招募4 期
Comparative Evaluation of Gingival Health with Preformed Zirconia Crown and Bioflx Crown in Primary Molars: A non-inferiority Randomized Clinical Trial
Dr Monica self1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年3月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To evaluate and compare the gingival health of primary molar teeth restored with preformed Zirconia crowns and preformed Bioflx crowns
研究概览
简要总结
Bioflx crowns have been introduced as an aesthetic alternative to the existing preformed Zirconia crowns. However, there is a scarcity of clinical data pertaining to its use. Thus, this non-inferiority randomized clinical trial is planned to evaluate and compare the clinical performance of Preformed Zirconia crowns and Preformed Bioflx crowns in terms of gingival health, restoration failure, color change in the crown with time, cavosurface marginal discoloration, opposing tooth wear, and the parental satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary molars indicated for full coverage restoration from Systemically apparently healthy patients in the age range of 4-8 years of either gender.
- •Primary teeth having at least two-thirds of root radiographically.
- •Primary teeth having at least one-third of crown structure.
排除标准
- •Root resorption due to any pathological reasons
- •Absence of any oral parafunctional habits in children.
结局指标
主要结局
To evaluate and compare the gingival health of primary molar teeth restored with preformed Zirconia crowns and preformed Bioflx crowns
时间窗: At 6 and 12 months
次要结局
- 1. To evaluate & compare the restoration failure.(2. To evaluate & compare the color change in the crown with time)
研究者
Dr Monica
Centre for Dental Education and Research AIIMS New Delhi
研究点 (1)
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