Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Occlusal Bite Force
研究概览
简要总结
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years requiring full-coverage restoration of primary molars will be randomly allocated to receive either Bioflx or zirconia crowns. Occlusal bite force will be assessed before treatment and at predefined postoperative follow-up time points using a digital occlusal analysis system. The study will evaluate changes in occlusal function following placement of the two types of pediatric full-coverage crowns.
详细描述
This randomized clinical trial aims to compare postoperative occlusal bite force following full-crown restoration of primary molars with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years who require full-coverage crown restoration of primary molars will be randomly allocated to receive either a preformed Bioflx crown or a zirconia crown. The crowns will be fitted and cemented according to the respective manufacturers' recommendations, and the final occlusion will be evaluated following crown placement.
Occlusal bite force will be assessed before treatment and at predetermined postoperative follow-up time points using a digital occlusal analysis system. The study will compare changes in bite force following restoration with Bioflx and zirconia crowns to evaluate the recovery of occlusal function after comprehensive dental treatment under general anesthesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-7 years.
- •Children requiring comprehensive dental treatment under general anesthesia.
- •Children requiring full-coverage restoration of one or more primary molars with a preformed pediatric crown.
- •Primary molars with sufficient remaining tooth structure to support full-crown restoration.
- •Children with a generally healthy medical status and suitable for treatment under general anesthesia.
- •Parents or legal guardians willing to provide written informed consent for participation in the study.
排除标准
- •Children with systemic diseases or medical conditions that may affect oral health, occlusal function, or the ability to undergo general anesthesia.
- •Children with craniofacial anomalies or developmental conditions that may significantly affect occlusion or bite force.
- •Primary molars with inadequate remaining tooth structure for full-crown restoration.
- •Teeth with advanced pathological root resorption or other conditions contraindicating crown restoration.
- •Children with significant parafunctional habits, such as severe bruxism, that may affect bite-force measurements.
研究组 & 干预措施
Bioflx Crown Group
Children in this group will receive full-crown restoration of indicated primary molars using preformed Bioflx pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.
干预措施: Preformed Bioflx Crown (Procedure)
Zirconia Crown Group
Children in this group will receive full-crown restoration of indicated primary molars using preformed zirconia pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.
干预措施: Preformed Zirconia Crown (Procedure)
结局指标
主要结局
Change in Occlusal Bite Force
时间窗: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
Change in occlusal bite force following full-crown restoration with preformed Bioflx or zirconia crowns, measured using a digital occlusal analysis system. Bite force will be expressed as the percentage (%) of total occlusal force contributed by the treated/restored primary molar(s).
次要结局
- Occlusal Contacts(Baseline, immediately after crown placement, and 1 and 3 month after treatment)
研究者
Shaimaa Shaban Mohamed El-desouky
Assistant professor of pediatric dentistry, Tanta University
Tanta University