Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Discoloration of teeth
研究概览
简要总结
The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.
详细描述
• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.
Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.
At the end of treatment, the access cavity will be sealed with composite restoration.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants/ outcome assessor will be blinded
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
- •Negative response of pulp tissue to electrical or thermal pulp tester.
- •Widening in lamina dura or periapical radiolucency not more than 3 mm.
排除标准
- •Patients having significant systemic disorder or immunocompromised patients.
- •Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.
- •Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).
- •Teeth with previous root canal.
- •Teeth need to post and core as final restoration
结局指标
主要结局
Discoloration of teeth
时间窗: Up to one Year after completion of regenerative endodontic treatment
Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.
次要结局
- Healing of Periapical Tissue(after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment)
- Restoring the sensibility of tooth(after 6,9 and Up to 12 months after completion of regenerative endodontic treatment)
研究者
Amatallah Hussein Nasser Al-Rawhani
Principle investigator
Cairo University