Vertical Dimension Changes and Mean Biting Force Following Bioflx Placement Over Pulp-treated Primary Molars Versus Stainless Steel Crowns: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Vertical dimension alterations
研究概览
简要总结
this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.
详细描述
Early childhood caries commonly affects primary molars and often requires full-coverage restoration after pulp therapy. Stainless steel crowns are widely used because of their durability and clinical success, but they may have limitations related to esthetics and acceptance. Bioflx crowns are a more esthetic and flexible alternative, but there is limited evidence comparing their functional performance with stainless steel crowns.
This parallel randomized controlled trial will be conducted at the outpatient clinic of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. A total of 18 children with pulp-treated primary molars will be enrolled and randomly allocated in a 1:1 ratio to receive either a Bioflx crown or a stainless steel crown.
The primary outcome is vertical dimension alteration measured in millimetres using a digital caliper. Secondary outcomes include mean biting force distribution measured by T-Scan digital occlusal analysis, parental satisfaction with esthetics, and parental satisfaction with treatment impact assessed by 5-point Likert scale questionnaires. Outcome measurements will be recorded at baseline, immediately after crown placement, at 1 week, and at 4 weeks, with parental satisfaction assessed at 4 weeks.
The purpose of this study is to determine whether Bioflx crowns provide comparable or improved functional and esthetic outcomes compared with stainless steel crowns in pulp-treated primary molars.
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
Participants and the operator are not blinded because of differences between the crown materials and their preparation. The statistician will be blinded.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulp-treated primary molars (pulpotomy)
- •Asymptomatic teeth after pulp therapy with no signs of infection, mobility, or radiographic pathology, such as internal resorption or periapical lesions
- •Age 6 years to 9 years
- •Male or female
- •Cooperative child with positive Frankl behavior rating
- •No missing teeth
- •Normal occlusion, including normal overjet and overbite
- •Free from systemic disease to allow continuity of follow-up
排除标准
- •Medically compromised or uncooperative children
- •Tooth indicated for extraction because of root resorption, teeth near exfoliation, or deep subgingival caries that prevents proper coronal seal
- •Teeth with more than two-thirds root resorption
- •Previous pulp therapy
- •Parafunctional habits, including bruxism, thumb-sucking, or other habits that may affect occlusal force measurements
- •Inability to attend follow-up visits or parental refusal to participate
研究组 & 干预措施
Bioflx Crown Group
Participants in this arm will receive Bioflx crowns after pulp therapy of primary molars. Crown placement will follow the study protocol, and outcomes including vertical dimension, mean biting force, and parental satisfaction will be assessed during follow-up.
干预措施: Bioflx Crown (Device)
Stainless Steel Crown Group
Participants in this arm will receive stainless steel crowns after pulp therapy of primary molars. Crown placement will follow the study protocol, and outcomes including vertical dimension, mean biting force, and parental satisfaction will be assessed during follow-up.
干预措施: Stainless Steel Crown (Device)
结局指标
主要结局
Vertical dimension alterations
时间窗: Baseline, immediately after crown placement, 1 week, and 4 weeks
Change in inter-occlusal vertical dimension measured in millimetres using a digital caliper at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Mean differences will be compared between the Bioflx crown group and the stainless steel crown group.
次要结局
- Mean Biting Force Distribution(Baseline, immediately after crown placement, 1 week, and 4 weeks)
- Parental Satisfaction With Treatment Impact(4 weeks)
研究者
Eman Adel Osman Hassan
Master's Degree Candidate, Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo University