Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- gingival health
研究概览
简要总结
• The goal of this clinical trial is to evaluate the clinical effectiveness of bioflex crowns and zirconia crowns compared to stainless steel crowns when
- restoring primary molars 45 participant who their ages range between 6 and 8 years participated in this study. The participants will be divided into three groups: group (A) for Bioflex crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15).
The periodontal health will be evaluated using gingival index and plaque index .Clinical success will be assessed according to the Modified United States Public Health Service Evaluation (USPHS) criteria regarding: crown retention ,marginal integrity, surface roughness and color change. Moreover, parental and child satisfaction will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Data analyst
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who are free from any systemic disease.
- •Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
- •Children with good to fair oral hygiene according to Loe and Silness plaque index.
- •Primary molars with deep carious lesion, that are indicated for pulpotomy and crown.
- •Primary molars having two-thirds of root structure left radiographically
- •Parents' willingness to participate through informed written consent
排除标准
- •Children with oral parafunctional habits.
- •Primary molars with bifurcation involvement
- •Presence of abscess or fistula related to the selected tooth
- •Primary molars with insufficient crown structure
研究组 & 干预措施
zerconia crown
干预措施: zerconia crown (Other)
stainless steel crown
干预措施: stainless steel crown (Other)
bioflex crown
干预措施: bioflex crown (Other)
结局指标
主要结局
gingival health
时间窗: follow up at 3,6 and 9 months
Evaluated using the gingival index, with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation).
次要结局
- parental satisfaction(3,6 and 9 months)
- plaque accumulation(3,6 and 9 months)
- crown retention(3,6 and 9 months)
- marginal integrity(3,6 and 9 months)
- color change(3,6 and 9 months)
- surface roughness(3,6 and 9 months)
- child post-operative discomfort(immediately post-operative and 48 hours post-operative)
研究者
Asmaa Yahia
principal investigator
Alexandria University