Diagnostic Accuracy of Cold, Heat, and Electric Pulp Tests

NCT07434622 | Completed FDA Device

• 2 other identifiers: 2024/48 Rev-2TITCK
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How accurately do cold, heat, and electrical pulp tests identify pulp vitality?
2. 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.

Conditions

Dental Pulp Disease; Pulp Necrosis; Pulpitis - Irreversible

Keywords

False responses; Predictive values; Pulp sensibility test; Sensitivity; Specificty

Outcome Measures

Primary Outcomes (1)

• Predictive values of pulp sensibility tests for pulp vitality

  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.

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

Secondary Outcomes (2)

• 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)

Other Outcomes (2)

• Overall diagnostic accuracy

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

• Agreement with reference standard

  Periprocedural (during access cavity preparation on Day 1)

Study Arms (1)

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.

Diagnostic Test: Pulp Sensibility Tests

Interventions

Pulp Sensibility Tests DIAGNOSTIC_TEST

Cold Pulp Sensibility Test (Refrigerant Spray) Refrigerant spray (propane-butane) is applied to a cotton pellet and placed on the tooth surface for up to 15 seconds (or stopped when the patient responds). Response is recorded as present/absent. 2\) Heat Pulp Sensibility Test (Frictional Heat) A sterile rubber cup on a low-speed handpiece is applied to the tooth surface without water cooling for up to 7 seconds (or stopped when the patient responds). Response is recorded as present/absent. 3\) Electric Pulp Test (EPT) An electric pulp tester is applied with toothpaste as a conducting medium to the tooth surface. Current is increased gradually; the perception threshold value is recorded and compared with a contralateral control tooth. Response is recorded as present/absent per the predefined rule.

Also known as: Heat Pulp Sensibility Test (Frictional Heat), Electric Pulp Test (EPT), Cold Pulp Sensibility Test (Refrigerant Spray)

Teeth Indicated for Root Canal Treatment (Adults)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from patients who presented to the Endodontics Clinic at Istanbul University Faculty of Dentistry (Istanbul, Türkiye), including patients referred from the Department of Oral and Maxillofacial Radiology, and who were evaluated in routine care and determined by clinicians to require endodontic treatment for at least one tooth.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Fatih, 34116, Turkey (Türkiye)

Location

Related Publications (9)

• Jespersen JJ, Hellstein J, Williamson A, Johnson WT, Qian F. Evaluation of dental pulp sensibility tests in a clinical setting. J Endod. 2014 Mar;40(3):351-4. doi: 10.1016/j.joen.2013.11.009. Epub 2013 Dec 15.

  PMID: 24565651 BACKGROUND

• Mejare IA, Bergenholtz G, Petersson K, Tranaeus S. Estimates of sensitivity and specificity of electric pulp testing depend on pulp disease spectrum: a modelling study. Int Endod J. 2015 Jan;48(1):74-8. doi: 10.1111/iej.12277. Epub 2014 Apr 2.

  PMID: 24579698 BACKGROUND

• Chen E, Abbott PV. Evaluation of accuracy, reliability, and repeatability of five dental pulp tests. J Endod. 2011 Dec;37(12):1619-23. doi: 10.1016/j.joen.2011.07.004. Epub 2011 Sep 9.

  PMID: 22099893 BACKGROUND

• Salgar AR, Singh SH, Podar RS, Kulkarni GP, Babel SN. Determining predictability and accuracy of thermal and electrical dental pulp tests: An in vivo study. J Conserv Dent. 2017 Jan-Feb;20(1):46-49. doi: 10.4103/0972-0707.209067.

  PMID: 28761253 BACKGROUND

• Villa-Chavez CE, Patino-Marin N, Loyola-Rodriguez JP, Zavala-Alonso NV, Martinez-Castanon GA, Medina-Solis CE. Predictive values of thermal and electrical dental pulp tests: a clinical study. J Endod. 2013 Aug;39(8):965-9. doi: 10.1016/j.joen.2013.04.019. Epub 2013 May 21.

  PMID: 23880259 BACKGROUND

• Weisleder R, Yamauchi S, Caplan DJ, Trope M, Teixeira FB. The validity of pulp testing: a clinical study. J Am Dent Assoc. 2009 Aug;140(8):1013-7. doi: 10.14219/jada.archive.2009.0312.

  PMID: 19654254 BACKGROUND

• Gopikrishna V, Tinagupta K, Kandaswamy D. Evaluation of efficacy of a new custom-made pulse oximeter dental probe in comparison with the electrical and thermal tests for assessing pulp vitality. J Endod. 2007 Apr;33(4):411-4. doi: 10.1016/j.joen.2006.12.003. Epub 2007 Feb 23.

  PMID: 17368329 BACKGROUND

• Peters DD, Baumgartner JC, Lorton L. Adult pulpal diagnosis. I. Evaluation of the positive and negative responses to cold and electrical pulp tests. J Endod. 1994 Oct;20(10):506-11. doi: 10.1016/S0099-2399(06)80048-8.

  PMID: 7714424 BACKGROUND

• Petersson K, Soderstrom C, Kiani-Anaraki M, Levy G. Evaluation of the ability of thermal and electrical tests to register pulp vitality. Endod Dent Traumatol. 1999 Jun;15(3):127-31. doi: 10.1111/j.1600-9657.1999.tb00769.x.

  PMID: 10530156 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Ayca Yilmaz, Assoc. Prof.

  Istanbul University

  STUDY DIRECTOR

• Ecem Erden Bozdağ

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Endodontics, Istanbul University Faculty of Dentistry

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start: June 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)