Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Clinical sucess
研究概览
简要总结
Early childhood caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Zirconia crowns have become a popular esthetic restorative option; however, limited evidence is available regarding the clinical performance of custom-made zirconia crowns compared with prefabricated zirconia crowns. This randomized controlled clinical trial aims to compare the clinical performance of custom-made and prefabricated zirconia crowns placed on pulpotomized primary molars. Clinical performance will be evaluated using standardized clinical and radiographic outcome measures over the follow-up period to determine whether custom-made zirconia crowns provide comparable or improved outcomes.
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 (Investigator)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-8 years.
- •Primary molars with deep carious lesions extending to the middle third of the dentin as confirmed radiographically.
- •Absence of root caries.
- •Absence of periapical or inter-radicular radiolucency.
- •Absence of internal or external root resorption.
- •Teeth in the opposite arch are present and in normal occlusion.
- •Willingness to participate and adhere to the follow-up appointments
排除标准
- •Children with systemic health issues.
- •Children with periodontal diseases.
- •Children exhibiting parafunctional habits.
- •Uncooperative children (Frankl scale (score 1 and 2).
结局指标
主要结局
Clinical sucess
时间窗: 12month
Clinical success will be determined according to the Modified USPHS criteria. Overall clinical success will be based on the combined assessment of marginal adaptation, retention, crown contour, and fracture.
次要结局
- Mean Gingival index(12month)
研究者
Esraa Sabry
Teaching assistant
Cairo University