Long-term Evaluation of Direct Pulp Capping Using Either Mineral Trioxid Aggregate or Calcium Hydroxide in Permanent Mature Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- clinical vital pulp therapy success
研究概览
简要总结
Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.
详细描述
Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.
The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.
A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.
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 (Participant)
盲法说明
patients are not aware about type of capping material used
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •carious teeth that had no previous root canal treatment
- •Pulpal diagnosis of normal or reversible pulpitis
排除标准
- •History of irreversible pulpal pain
- •Immature teeth
- •Non restorable teeth
- •Teeth with active periodontal disease
- •History of any systemic disease
- •Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
研究组 & 干预措施
calcium hydroxide direct pulp capping
calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group
干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)
MTA direct pulp capping
Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group
干预措施: Mineral Trioxide Aggregate (Drug)
结局指标
主要结局
clinical vital pulp therapy success
时间窗: from date of randomization until failure reported for up to 100 months
Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs
次要结局
- Radiographic success(from date of randomization until failure reported for up to 100 months)