Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change in pain symptoms
研究概览
简要总结
Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.
详细描述
Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.
The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.
Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent teeth with mature or immature apices
- •Have no significant medical problems
- •The tooth should give positive response to cold test and electric pulp test (EPT)
- •Probing pocket depth and mobility within normal limits
- •No Signs of pulp necrosis including sinus tract or swelling
- •Radiographically ; caries either exposing the pulps or reaching more than 2\3 the distance from the dentino-enamel junction (DEJ) to the pulp
- •The tooth can be restored via direct restoration
排除标准
- •Medically compromised patients
- •Negative response to cold test
- •Sinus tract
- •Non restorable teeth or badly broken teeth
结局指标
主要结局
Change in pain symptoms
时间窗: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.
The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.
次要结局
- The tooth and restoration should be present in the mouth(3, 6 months, 1 year, 2, 3,4,5 years)
- Periapical normalcy at follow up radiographs .(6months , 1 year, 2, 3,4,5 years)