Short Term Success of Inflamed Mature Single Rooted Teeth With Symptomatic Apical Periodontitis Following Single Visit Regenerative Treatment Protocols (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of tooth Sensitivity
研究概览
简要总结
The majority of articles present in literature concerning the enrollment of tissue engineering in the field of root canal treatment is concerned with the treatment of affected teeth with immature apex, after proper systematic search online, only 4 articles where found that are dealing with the treatment of teeth with mature apex. These 4 studies are case reports. None of these studies has been a randomized clinical trial, the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Since that the triad of regenerative endodontics are the key of success of any attempt to regenerate pulp, 2 different maneuvers shall be done in this study.
详细描述
Preservation of the natural dentition had always been a primary objective in endodontic practice. When the pulp is diseased or requires removal for restorative reasons, it is replaced with an artificial filling material during conventional root canal treatment. Root canal treatment has lots of drawbacks, starting with different iatrogenic errors during endodontic procedures, weakening of remaining tooth structure which might affect the tooth survival. Also Root canal treated teeth require the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it. The most important drawback is that the survival of affected pulp is hindered by the conventional root canal treatment. Thus a new treatment approach was introduced utilizing the body ability to regenerate, called Pulp Regeneration. Regeneration was first introduced in the dental field as a solution for immature apex treatment, due to difficulties encountered during its conventional root canal treatment. Here the Pulp regeneration shall be used on vital mature teeth to increase the survival rate of the affected teeth.
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, Investigator)
盲法说明
Sealed Opaque Envelopes
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
- •Non-pregnant females
- •Single canalled teeth.
- •Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
- •Positive patient/Guardian compliance for participation in the study.
排除标准
- •Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
- •Non-restorable coronal portion of teeth involved in the trial.
- •Non Vital teeth
- •Immature teeth
- •Traumatized teeth
- •Radiographic evidence of external or internal root resorption.
- •Single Rooted teeth with multiple canals.
结局指标
主要结局
Change of tooth Sensitivity
时间窗: 1, 3, 6, 9, 12 Months
Electric Pulp Tester
次要结局
- Periapical Status(1, 3, 6, 9, 12 Months)
- Survival(1, 3, 6, 9, 12 Months)
- Clinical Success(1, 3, 6, 9, 12 Months)
- Pericapical Status(6, 9, 12 Months)
研究者
Mostafa Omar Fahim
Assistant Lecturer of Endodontics
Cairo University