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临床试验/CTRI/2024/08/072430
CTRI/2024/08/072430尚未招募不适用

Diagnostic accuracy of thermal and electric pulp tests for pulp sensibility assessment after pulpotomy - a histomorphometric study

Centre for Dental Education and Research1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年8月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
72
试验地点
1
主要终点
1. Assessment of the tooth response to cold test after partial and complete pulpotomy

研究概览

简要总结

The pulpotomy procedure is based on the principles of minimal intervention dentistry and is aimed at the preservation of radicular pulp. It has been proposed as an alternative to root canal treatment for the management of carious exposed teeth. Based on the current outcome assessment criteria, the pulpotomy procedure is considered successful if the patient is asymptomatic and the radiograph reveals normal periapical architecture. This provides an indirect assessment of pulp survival after pulpotomy. Pulp sensibility tests, which stimulate the dental nerve fibers, are diagnostic aids for determining the status of pulp in routine clinical practice. It is assumed that the pulpotomized teeth do not respond to pulp sensibility tests due to the absence of coronal pulp tissue and the presence of heavy restoration in the pulp chamber. Therefore, the position statement by the European Society for Endodontology (ESE) does not include the use of a pulp sensibility test in the outcome assessment criteria. On the contrary, the findings of a retrospective study done at our department and limited published literature in peer-reviewed international journals suggests that the pulp sensibility tests can elicit a response in pulpotomized teeth and can be used as a tool to determine the pulp survival after pulpotomy procedure. However, every test, even with the highest level of precision, will misclassify a certain proportion of patients. Hence, it is important to determine the accuracy of a test to classify a patient’s response before it can be proposed as a tool for outcome assessment. To characterize the pulp sensibility test’s accuracy, histological examination is considered as the gold standard reference. Till date to the best of our knowledge, there is no study in the literature that compares the responses of pulp sensibility tests and the histological status of pulp after the pulpotomy procedure (partial or complete) in permanent teeth. Hence, the current study is planned with the primary goal of evaluating the diagnostic accuracy of pulp sensibility tests (thermal and electric pulp test) after partial and complete pulpotomy in permanent teeth.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
9.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Young patients with maxillary premolar teeth indicated for extraction due to orthodontic reasons and who are willing to volunteer for the study will be included in the study.
  • Maxillary premolar teeth having occlusal carious lesions with pulp exposure and symptomatic irreversible pulpitis.

排除标准

  • Teeth having cracks, cusp fractures, carious lesions with pulp necrosis or periapical lesion and poor periodontal health.
  • Teeth which are not able to be isolated with rubber dam.
  • Patients with systemic conditions which could compromise the healing.
  • Patients not willing to participate in the study.

结局指标

主要结局

1. Assessment of the tooth response to cold test after partial and complete pulpotomy

时间窗: Patients will be recalled after three months for evaluation of the outcome

procedure.

时间窗: Patients will be recalled after three months for evaluation of the outcome

2. Assessment of the tooth response to heat test after partial and complete pulpotomy

时间窗: Patients will be recalled after three months for evaluation of the outcome

3. Assessment of the tooth response to electric pulp test after partial and complete

时间窗: Patients will be recalled after three months for evaluation of the outcome

pulpotomy procedure.

时间窗: Patients will be recalled after three months for evaluation of the outcome

4. Evaluation of the histological outcome of partial and complete pulpotomy.

时间窗: Patients will be recalled after three months for evaluation of the outcome

5. Establishment of an association between response to pulp sensibility test and

时间窗: Patients will be recalled after three months for evaluation of the outcome

histologic pulp status.

时间窗: Patients will be recalled after three months for evaluation of the outcome

次要结局

  • 1. Determination of the appropriate site for cotton pellet placement for cold test in(teeth after partial and complete pulpotomy procedure.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Pavithra R

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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