Comparison of Human Pulpal Response After Pulpal Exposure to Common Treatments and Single-visit MTA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- histologic findings - inflammation of the pulp
研究概览
简要总结
Application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.
详细描述
The purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation & dentinal bridge formation. Methods: Eight patients providing 32 sound first premolars are selected. As recommended by ISO / TC 7405 pulpal exposure will be performed through a class I cavity. Four groups of eight specimens each will be defined according to the pulp capping method. Group A, will receive chemical set calcium hydroxide (Dycal). Group B, will receive mineral Trioxide Aggregate (MTA) according to manufacturer's instruction. Group C, will receive MTA and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. Group D, will receive Multical as a direct pulp capping agent. Specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. The last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. In case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by ISO / TC 7405.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aging from 10 to 16
- •Patients who need to extract 4 premolars for orthodontic purposes
- •the teeth should be free of caries and clinical symptoms
- •Through thermal tests and radiographic examination absence of any pathology is confirmed.
- •Periapical radiographs demonstrating absence of any pathology
- •no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with Green Endo Ice refrigerant spray, heat sensitivity after applying tempered Gutta Percha for 10 seconds.
- •Absence of any systematic disorder
- •No consumption of drugs of any kind
- •All patients and their parents need to sign a fully informed consent.
排除标准
- •If any of the teeth shows caries, restoration, crack or hypocalcification
- •presence of any periapical pathosis
- •Teeth that seem sensitive to cold, hot, percussion or pressure
- •any systematic disorder
- •consumption of drugs of any kind.
研究组 & 干预措施
Pro Root MTA- standard method
application of MTA in second group and 24 hour interval before restoration
干预措施: Pro Root MTA (Drug)
Pro Root MTA- single visit
Intervention/Control application of MTA in third group and 15 minute interval before restoration
干预措施: Pro Root MTA- single visit (Drug)
MultiCal / LimeLite
application of Multical in forth group
干预措施: MultiCal (Drug)
Dycal
application of Dycal in first group as a pulp dressing agent
干预措施: Dycal (Drug)
结局指标
主要结局
histologic findings - inflammation of the pulp
时间窗: 6weeks
According to histological evaluation and ISO/DIS7405, the investigators gave to non inflamed cases no points, mild cases 1 point, moderate cases 2 points, severe cases 3 points and necrosis 4 points.
次要结局
- histologic findings - formation of the dentinal bridge(6 weeks)
研究者
Mahta Fazlyab
Post graduate student of endodontics
Islamic Azad University, Tehran