TCTR20170526003招募中未知
Outcomes of Direct Pulp Capping Using Either ProRoot MTA® or Biodentine™ in Permanent Teeth With Carious Pulp Exposure in 6-18-year-old Patients.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Patient inclusion criteria
- •1. American Society of Anesthesiologists I or II (ASA I or II) pediatric patients aged between 6 and 18 years
- •2. Cooperative patients
- •3. The legal guardians allow the child participate and the child agrees to participate in the study and sign the informed consent and assent forms, respectively
- •Tooth clinical inclusion criteria
- •Pre-operative clinical inclusion criteria
- •1. Tooth with deep caries diagnosed with normal pulp, reversible pulpitis or irreversible pulpitis
- •2. Tooth that has a positive response to sensibility test (cold test)
- •3. Tooth that is restorable with resin composite filling or stainless steel crown
- •4. Absence of clinical swelling, pus exudate/ fistula of soft and periodontal tissues
- •5. Absence of abnormal tooth mobility
- •Intra-operative clinical inclusion criteria
- •1. After complete caries removal procedure, exposure of pulpal tissue occurs
- •2. Size of pulp exposure is < 2.5 mm. in diameter
- •3. Pulp tissue appears healthy judged from color and amount of bleeding
- •4. Bleeding from pulp exposure site can be controlled within 10 minutes
- •Radiographic inclusion criteria
- •Bitewing radiograph
- •1.The extension of the dental caries radiolucency penetrates into three fourths or more of the entire dentin thickness
- •Paralleled periapical radiograph
- •1. Absence of internal and pathologic external root resorption
- •2. Absence of pulp calcification pulp canal obliteration
- •3. Absence of periapical and furcation radiolucency
- •Note: Presence of widened PDL space or evidence of condensing osteitis are not exclusion criteria for this study
排除标准
- •Patient exclusion criteria
- •Pediatric patients who have a systemic disease that is contraindicated for vital pulp therapy, such as congenital heart disease, bleeding disorder, etc.
- •Tooth clinical exclusion criteria
- •Intra-operative clinical exclusion criteria
- •1. After caries is completely removed, no pulp exposure is detected by visual or tactile methods, or pulp exposure size is larger than 2.5 mm.
- •2. Bleeding from pulp exposure site cannot be controlled within 10 minutes
- •3. Pulp tissue appears necrotic judged on the absence of bleeding or the presence of pale pulp tissue.
研究者
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