3D-printed Endocrowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars ; In-Vivo and In-Vitro Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- clinical performance
研究概览
简要总结
Aim of the study :
to compare between 3D printed microfilled hybrid composite endocrowns and prefabricated zirconia crowns for restoring pulpally treated primary molars regarding the following aspects: In Vivo aspects Patient satisfaction
*The esthetic, functional and biological performance according to FDI clinical criteria. At 3, 6 and 12 months
In Vitro aspects:
- Marginal gap.
- Fracture resistance.
Study methodology:
This study is a combined randomized clinical trial and in vitro study .The study will be conducted at the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry,
Ain Shams University as follows:
In vivo comparison of the clinical performance of 3D printed Endocrowns versus prefabricated zirconia crowns regarding esthetic, functional and biological performance according to FDI clinical criteria. In vitro evaluation of the marginal gap and fracture resistance of both types of restorations.
详细描述
Study Procedure:
In-vivo Phase:
Study Population:
A total of thirty primary mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. Randomization The molars will be assigned to one of the 2 groups using a generated computer list Allocation The molars will be allocated to the groups via a third party not involved with the study They will have the generated list and inform the allocation accordingly Blinding Is not possible due to the obvious difference between the 2 Pulpotomy procedure for both groups:
- Local anesthesia will be administered.
- Teeth will be isolated by a Rubber Dam.
- Teeth will undergo pulpotomy procedure' as follows:
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
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
- •The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.
- •Exclusion criteria:
- •Children who are uncooperative needing sedatin or general anasthesia.
- •Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- •e) Teeth of poor prognosis due to th e presence of an abscess or a sinus, mobility, advanced bone or root resorption.
排除标准
- 未提供
结局指标
主要结局
clinical performance
时间窗: 6 months
Federation Dentaire international clinical assessment scale. Minimum value is 1 and highest value is 11. Higher values mean worst outcome.
次要结局
- patient satisfaction(6 months)
研究者
Lamia Hussein
principal investigator
Ain Shams University