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临床试验/NCT07434622
NCT07434622已完成不适用

Diagnostic Accuracy of Cold, Heat, and Electric Pulp Tests: An In Vivo Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2024年6月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
Predictive values of pulp sensibility tests for pulp vitality

研究概览

简要总结

The goal of this observational study is to evaluate the diagnostic accuracy of cold, heat, and electrical pulp tests in adults with teeth suspected of requiring endodontic treatment. The main questions it aims to answer are:

  1. How accurately do cold, heat, and electrical pulp tests identify pulp vitality?
  2. How do these tests compare with direct visual inspection of pulp bleeding during endodontic access (reference standard)? Participants attending The University Endodontics Clinic with at least one tooth indicated for endodontic access will receive cold, heat, and electrical pulp testing as part of the clinical examination. The test responses will be recorded and compared with the presence or absence of pulp bleeding observed directly after access cavity preparation.

详细描述

This is a prospective, in vivo, observational diagnostic accuracy study conducted at the Endodontics Clinic of Istanbul University Faculty of Dentistry. The protocol was approved by the Ethical Committee of Istanbul University Faculty of Dentistry (Ref. 2024/48 Rev-2) and registered in the Turkish Medicines and Medical Devices Agency (Protocol No. 2023/38). The study was performed in accordance with the Declaration of Helsinki, and written informed consent was obtained prior to study procedures. Before study initiation, the research team was trained and calibrated for the testing protocol and data collection.

Eligible adult participants presenting with at least one tooth indicated for root canal treatment were recruited during routine clinical care. One tooth per participant was included. Eligibility criteria and exclusions were defined a priori and are described in the Eligibility module.

Index Tests (Pulp Sensibility Tests) All index tests were performed by a single operator who was blinded to the participants' clinical signs/symptoms, dental history, and radiographic findings. Participants were instructed to raise their hand immediately when they perceived pain, discomfort, or tingling.

To establish an individual baseline response, testing was first performed on an asymptomatic, functional contralateral tooth without prior endodontic treatment; if unavailable, an adjacent tooth meeting these criteria was used. The study (index) tooth was tested last. Teeth were isolated with cotton rolls and dried with an air syringe before each test. Tests were applied to standardized anatomical sites (incisors/canines: middle third of buccal surface; premolars: occlusal third; molars: mesiobuccal cusp tip area or the closest available site). Responses were recorded dichotomously as "response present" or "response absent" (response time and intensity were not measured). The three tests were performed in the following order, with a 5-minute interval between tests to minimize carryover effects:

Cold test: Refrigerant spray containing propane-butane (Endo-Frost; Roeko, Coltene Whaledent, Germany) was applied to a size 2 cotton pellet. Once frosting was visible, the pellet was placed on the standardized site for up to 15 seconds or until the participant responded.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • At least one tooth indicated for root canal treatment confirmed at the Endodontics initial examination unit
  • Able and willing to provide written informed consent

排除标准

  • Tooth-related
  • Full-coverage crown
  • Extensive restoration affecting testing area
  • History of dental trauma (for the study tooth)
  • Root resorption
  • Incomplete root development (open apex)
  • Tooth fracture or crack
  • Regressed pulp chamber / pulp canal obliteration or calcified root canals Patient-related
  • Severe or uncontrolled systemic disease: ASA physical status 3-6

研究组 & 干预措施

Teeth Indicated for Root Canal Treatment (Adults)

Adults (≥18 years) with at least one tooth indicated for root canal treatment (one tooth per participant). Each included tooth undergoes cold, heat, and electric pulp testing; pulp status is classified by the reference standard (presence/absence of pulpal bleeding during access cavity preparation). The cohort includes teeth ultimately classified as vital and non-vital by the reference standard; no separate comparison cohort is enrolled.

干预措施: Pulp Sensibility Tests (Diagnostic Test)

结局指标

主要结局

Predictive values of pulp sensibility tests for pulp vitality

时间窗: Periprocedural (during pulp testing and access cavity preparation on Day 1)

Positive predictive value (PPV) and negative predictive value (NPV) of cold, heat, and electric pulp tests for identifying pulp vitality, calculated against the reference standard (presence/absence of pulpal bleeding during access cavity preparation). PPV/NPV are derived from the observed false-positive and false-negative results for each test.

次要结局

  • False-positive and false-negative responses(Periprocedural (during pulp testing and access cavity preparation on Day 1))
  • Sensitivity and specificity(Periprocedural (during pulp testing and access cavity preparation on Day 1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ecem Erden Bozdağ

Research Assistant, Department of Endodontics, Istanbul University Faculty of Dentistry

Istanbul University

研究点 (1)

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