Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 主要终点
- Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
研究概览
简要总结
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.
详细描述
Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures
- •Teeth that can have hemostasis can be achieved with pressure
- •No clinical symptoms
- •No radiographic signs of internal resorption or external root resorption
排除标准
- •Primary Molars diagnosed with irreversible pulpitis or necrotic pulp
- •Teeth that can not achieve hemostasis
- •Teeth with abscess or fistula
- •Teeth that have radiographic signs of internal resorption or external resorption
研究组 & 干预措施
Mineral Trioxide Aggregate
Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth
干预措施: MTA (Device)
Ferric Sulfate
Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
干预措施: Ferric Sulfate (Drug)
结局指标
主要结局
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
时间窗: 1 year
At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test
次要结局
未报告次要终点
研究者
Jung-Wei Chen, DDS, MS, PhD
Pediatric Dental Director
Loma Linda University