3D-Printed Crowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars; Randomized Clinical Trial and In-Vitro Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Gingival health (gingival index)
研究概览
简要总结
The aim of the present study is to compare between 3D-printed crowns and prefabricated zirconia crowns for restoring pulpally-treated primary molars regarding the following aspects:
- In vivo:
Evaluate the clinical outcome of 3D printed crowns in comparison to prefabricated zirconia crowns in pulpally-treated primary molars as well as parent satisfaction. 2. In vitro:
Comparative analysis of fracture resistance and marginal gap of 3D printed crowns and prefabricated zirconia crowns
详细描述
in vitro part :
All selected primary molars should fulfill the following criteria:
- Freshly extracted molars with at least three sound walls.
- Retain at least one third of their roots Teeth preparation All soft tissue debris will be removed with a hand scaler and teeth will be disinfected, and then stored in distilled water at 4 degrees Celsius until the start of the study.
Pulpotomy procedures will be performed to the extracted molars and the molars will be filled. Then, they will be randomly allocated into two groups.
Group 1: Will receive 3D-printed crowns Group 2: Will receive prefabricated zirconia crowns The specimens will be embedded perpendicularly in Polyvinyl chloride (PVC) cubes with the occlusal surface parallel to the ground using acrylic resin extending 2mm below the cementoenamel junction.
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
- 是
入选标准
- •Children included in the study should stratify to the following criteria:
- •Age range of children from 4 -7 years.
- •Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
- •The expected exfoliation date of the selected primary teeth must be more than 12 months from the start date of the study.
排除标准
- •a) Uncooperative children who needs sedation or general anesthesia. b) Children with physical, intellectual disability or medical conditions that may complicate treatment.
- •c) Teeth with poor prognosis due to the presence of an abscess or a sinus, mobility or advanced bone resorption.
- •d) Presence of internal or external root resorption.
结局指标
主要结局
Gingival health (gingival index)
时间窗: 1 year follow up for vivo part only
Gingival index and plaque index A gingival index, based on the Loe and Silness scoring criteria (1963). It will be measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each tooth. Scoring as followed: 0 = Normal (Absence of inflammation) 1. = Mild gingivitis (slight change in color, slight edema. No bleeding on probing) 2. = Moderate gingivitis (redness, edema and glazing. Bleeding on probing) 3. = Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding) * Gingival index and plaque index.
crown retention
时间窗: one year follow up
Alpha: Bonded Bravo: Debonded Charlie: Lost
In vitro marginal gap
时间窗: Immediately after samples preparation
micrometers
plaque index
时间窗: 1year follow up
Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental
Marginal integrity
时间窗: 1yeat follow up
by visual inspection and explorer Alfa: Explorer does not catch or has one way catch when drawn across the restoration/tooth interface. Bravo: Explorer falls into crevice when drawn across the restoration/tooth interface, Dentin is not exposed; clinically acceptable. Charlie: Dentin or base is exposed along the margin; clinically unacceptable.
in vitro fracture resistance
时间窗: Immediately after samples preparation
newton
次要结局
- parent satisfaction(immediately after cementation of crowns)
研究者
Esaad El Nagar
Assistant lecturer at pediatric dentistry and dental public health department
Ain Shams University