NCT04385693已完成不适用
Intentional Pulpotomy to Preserve Vital Primary Molars With Challenging Restorability: a Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Radiographic examination for each recall visit
研究概览
简要总结
When proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended. Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the CEJ
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Selected patients will have one or more primary molar teeth diagnosed clinically with large proximal carious lesions with the gingival extension of the cavity at or below the cemento-enamel junction. The tooth should be asymptomatic and must have no signs of swelling, fistula, abnormal mobility and sensitivity to percussion (ruling out food impaction), and adequate space for placement of a stainless steel crown restoration. The pre-operative periapical radiograph, taken as part of the new patient/recall routine visit, should reveal a lesion in close approximation to the pulp, but having at least 1-2 mm of sound dentin separating the deepest portion of the lesion and the pulp. In addition, no evidence of furcation and periapical pathology, internal or external root resorption and presence of half to two-thirds of root length remaining.
排除标准
- •Uncooperative patients
- •Teeth with positive history of pain, abnormal mobility, signs of pulp necrosis such as presence of swelling or fistula, and significant space loss due to caries not allowing placement of a stainless steel crown restoration
- •Radiographically, signs of furcation and periapical pathology, internal and external resorption, less than half to 2/3 of root length remaining
- •Selected patients will be treated by pediatric dental residents in the regular dental clinic setting with or without nitrous oxide inhalation, as part of the standard of care
- •Prior to the beginning of the study, all operators will be calibrated by the principal investigator on identifying the teeth in question, as well as on the restorative technique
- •Selected patients may have one or more qualified teeth
结局指标
主要结局
Radiographic examination for each recall visit
时间窗: up to 1 year
Evaluation of asymptomatic tooth in the mouth for presence of infection (bite -wing/periapical radiograph(s)
次要结局
未报告次要终点
研究者
研究点 (2)
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