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临床试验/CTRI/2020/09/028105
CTRI/2020/09/028105尚未招募2 期

Evaluation of one versus two step technique on the outcome of mineral trioxide aggregate pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis – A prospective clinical study

Centre for Dental Education and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1) To evaluate and compare the treatment outcoome of MTA pulpotomy used for the management of teeth with symptoatic irreverible pulpitis by :

研究概览

简要总结

Symptomatic irreversible pulpitis is an abnormal condition characterized by severe pain which lingers even after the removal of stimulus and is spontaneous. According to the older concept, pulp once inflamed gets affected in toto and treatment requires complete removal of diseased pulp tissue from root canal space. However, new concept refutes the older one and states that pulpal inflammation occurs by tissue compartment and even in the cases of irreversibly inflamed pulp, there are areas of uninflamed and disease free pulp tisuue. This has led to a paradigm shift in the treatment protocol from root canal treatment to pulp preservation by pulpotomy. MTA is currently the most preferred material for pulpotomy. But MTA have a long setting time. Hence, it is advised to place a final definitive restoration over MTA after 24 hours. This two-step MTA pulpotomy technique have certain disadvantages such as more time consuming, increased chances of possible iatrogenic errors,Inceased cost and increased chances of microleakage. However, current evidences from recent in-vitro studies suggests that glass ionomer cement can be placed over MTA in same visit without any adverse reaction between the two materials. Till this date there are no clinical studies in the literature that has compared one and two step technique for MTA pulpotomy. Hence, it is proposed to conduct a comparative study for the evaluating the outcome of MTA pulpotomy after one and two step technique.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients of either gender between 15-35 years of age with mature mandibular 1st and 2nd molar with established clinical diagnosis of symptomatic irreversible pulpitis without periapical rarefaction.
  • Positive response to cold and electric pulp test.
  • Teeth with restorable carious lesion.

排除标准

  • Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health.
  • Patients with systemic conditions which would compromise healing.
  • Patients not willing to participate in the study.

结局指标

主要结局

1) To evaluate and compare the treatment outcoome of MTA pulpotomy used for the management of teeth with symptoatic irreverible pulpitis by :

时间窗: T0 Preoperative IOPAR before starting the procedure. | T6 Post operative IOPAR approximately after 6 months. | T12 Post operative IOPAR after 12 months.

b) Two Step Technique

时间窗: T0 Preoperative IOPAR before starting the procedure. | T6 Post operative IOPAR approximately after 6 months. | T12 Post operative IOPAR after 12 months.

a) One step Technique and

时间窗: T0 Preoperative IOPAR before starting the procedure. | T6 Post operative IOPAR approximately after 6 months. | T12 Post operative IOPAR after 12 months.

次要结局

  • 1) To evaluate the functional and biological parameters of final restorations.(2) To evaluate the pulp vitality status after pulpotomy with electric and cold test.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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