Dental Pulp DiseaseNCT07434622
Diagnostic Accuracy of Cold, Heat, and Electric Pulp Tests
An observational study of Dental Pulp Disease and Pulp Necrosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. How accurately do cold, heat, and electrical pulp tests identify pulp vitality? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dental Pulp Disease, Pulp Necrosis, Pulpitis - Irreversible
- What is being tested?
- Pulp Sensibility Tests
- How many people
- 175 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, Fatih, 34116
About this study
Official title: Diagnostic Accuracy of Cold, Heat, and Electric Pulp Tests: An In Vivo Study
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:
- How accurately do cold, heat, and electrical pulp tests identify pulp vitality?
- 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.
Read the detailed description
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.
Heat test (frictional heat): A sterile rubber cup (NAIS, Sofia, Bulgaria) mounted on a low-speed contra-angle handpiece at a constant speed setting was applied with light, consistent contact without water cooling. The stimulus was stopped when the participant responded or after a maximum of 7 seconds.
Electric pulp test (EPT): An apex locator with integrated pulp tester (Ai-Pex; Woodpecker, Guilin, P.R. China) was used with toothpaste as a conducting medium on a 2-mm electrode tip. The current was increased at the lowest ramp setting, and the numeric value at first perception was recorded. The contralateral tooth served as the control. If the response for the index tooth occurred at a value equal to or lower than the control, the result was recorded as "response present"; if a higher value was required or no response occurred up to the maximum value (80), the result was recorded as "response absent."
Reference Standard (Pulpal Bleeding) Immediately after completion of the index tests, local anesthesia (Ultracain D-S Forte; Sanofi, Paris, France) was administered and rubber dam isolation was applied. A standard endodontic access cavity was prepared by a second researcher who was blinded to the pulp test results. The presence or absence of pulpal bleeding in the pulp chamber was assessed by direct visual inspection under 3.5× magnification (dental loupes) and recorded as present/absent. Teeth were classified as vital when bleeding was observed within the pulp chamber. Teeth were classified as non-vital when no bleeding was present in the pulp chamber. Cases with bleeding limited to root canal(s) without pulp chamber bleeding, or bleeding not present in all canals of multi-rooted teeth, were classified as partially necrotic and recorded as non-vital. Teeth with uncertain pulp status were excluded. Following reference standard assessment, root canal treatment was performed as planned.
Statistical Approach For each index test, true-positive, false-positive, true-negative, and false-negative values were determined against the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated and reported with 95% confidence intervals (Wilson score method). Agreement between each test and the reference standard was assessed using Cohen's kappa. Differences among the three tests were evaluated using Cochran's Q test, and pairwise comparisons were performed using Bonferroni-adjusted Z tests. Analyses were conducted using IBM SPSS Statistics (Version 23; IBM Corp., Armonk, NY, USA), with statistical significance set at p<0.05.
- Conditions
- Dental Pulp Disease, Pulp Necrosis, Pulpitis - Irreversible
- Being tested
- Pulp Sensibility Tests
- Keywords
- False responses, Predictive values, Pulp sensibility test, Sensitivity, Specificty
- Medical subject headings
- Dental Pulp Diseases, Dental Pulp Necrosis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp Sensibility TestsDiagnostic test
Also called Heat Pulp Sensibility Test (Frictional Heat), Electric Pulp Test (EPT), Cold Pulp Sensibility Test (Refrigerant Spray)
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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Pulp Sensibility Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural (during pulp testing and access cavity preparation on Day 1)
Secondary outcomes (2)
False-positive and false-negative responses
Number and proportion of false-positive and false-negative responses for each pulp test compared with the reference standard (pulpal bleeding).
Measured: Periprocedural (during pulp testing and access cavity preparation on Day 1)
Sensitivity and specificity
Sensitivity and specificity of each pulp test versus the reference standard (pulpal bleeding) based on 2×2 contingency tables.
Measured: Periprocedural (during pulp testing and access cavity preparation on Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start30 Jun 2024
- Primary completion30 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Erden Bozdağ, Istanbul University
- Investigators
- Ayca Yilmaz, Assoc. Prof., Study director, Istanbul UniversityEcem Erden Bozdağ, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434622
- Sponsor's protocol ID
- 2024/48 Rev-2
- Other IDs
- TITCK
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent and ethics approval did not include public data sharing, and the dataset contains potentially identifiable clinical information.
Publications
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.
PubMed 24565651Mejare 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.
PubMed 24579698Chen 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.
PubMed 22099893Salgar 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.
PubMed 28761253Villa-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.
PubMed 23880259Weisleder 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.
PubMed 19654254Gopikrishna 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.
PubMed 17368329Peters 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.
PubMed 7714424Petersson 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.
PubMed 10530156
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Cold, Heat, and Electric Pulp Tests: An In Vivo Study
- ClinicalTrials.gov ID
- NCT07434622
- Acronym / sponsor ID
- 2024/48 Rev-2
- Conditions
- Dental Pulp Disease, Pulp Necrosis, Pulpitis - Irreversible
- Keywords
- False responses, Predictive values, Pulp sensibility test, Sensitivity, Specificty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How accurately do cold, heat, and electrical pulp tests identify pulp vitality?
- 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.
Detailed description
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.
Heat test (frictional heat): A sterile rubber cup (NAIS, Sofia, Bulgaria) mounted on a low-speed contra-angle handpiece at a constant speed setting was applied with light, consistent contact without water cooling. The stimulus was stopped when the participant responded or after a maximum of 7 seconds.
Electric pulp test (EPT): An apex locator with integrated pulp tester (Ai-Pex; Woodpecker, Guilin, P.R. China) was used with toothpaste as a conducting medium on a 2-mm electrode tip. The current was increased at the lowest ramp setting, and the numeric value at first perception was recorded. The contralateral tooth served as the control. If the response for the index tooth occurred at a value equal to or lower than the control, the result was recorded as "response present"; if a higher value was required or no response occurred up to the maximum value (80), the result was recorded as "response absent."
Reference Standard (Pulpal Bleeding) Immediately after completion of the index tests, local anesthesia (Ultracain D-S Forte; Sanofi, Paris, France) was administered and rubber dam isolation was applied. A standard endodontic access cavity was prepared by a second researcher who was blinded to the pulp test results. The presence or absence of pulpal bleeding in the pulp chamber was assessed by direct visual inspection under 3.5× magnification (dental loupes) and recorded as present/absent. Teeth were classified as vital when bleeding was observed within the pulp chamber. Teeth were classified as non-vital when no bleeding was present in the pulp chamber. Cases with bleeding limited to root canal(s) without pulp chamber bleeding, or bleeding not present in all canals of multi-rooted teeth, were classified as partially necrotic and recorded as non-vital. Teeth with uncertain pulp status were excluded. Following reference standard assessment, root canal treatment was performed as planned.
Statistical Approach For each index test, true-positive, false-positive, true-negative, and false-negative values were determined against the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated and reported with 95% confidence intervals (Wilson score method). Agreement between each test and the reference standard was assessed using Cohen's kappa. Differences among the three tests were evaluated using Cochran's Q test, and pairwise comparisons were performed using Bonferroni-adjusted Z tests. Analyses were conducted using IBM SPSS Statistics (Version 23; IBM Corp., Armonk, NY, USA), with statistical significance set at p<0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teeth Indicated for Root Canal Treatment (Adults) | – | Diagnostic Test: Pulp Sensibility TestsAdults (≥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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Tooth-related
- Full-coverage crown
- Extensive restoration affecting testing area
- History of dental trauma (for the study tooth)
- Root resorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulp Sensibility TestsAlso: Heat Pulp Sensibility Test (Frictional Heat), Electric Pulp Test (EPT), Cold Pulp Sensibility Test (Refrigerant Spray)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. | Diagnostic test | Teeth Indicated for Root Canal Treatment (Adults) |
Primary outcome
Predictive values of pulp sensibility tests for pulp vitality
Time frame: 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.
2 secondary outcomes
False-positive and false-negative responses
Time frame: Periprocedural (during pulp testing and access cavity preparation on Day 1)
Sensitivity and specificity
Time frame: Periprocedural (during pulp testing and access cavity preparation on Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 24565651Jespersen 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.
- Background: PubMed 24579698Mejare 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.
- Background: PubMed 22099893Chen 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.
- Background: PubMed 28761253Salgar 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.
- Background: PubMed 23880259Villa-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.
- Background: PubMed 19654254Weisleder 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.
- Background: PubMed 17368329Gopikrishna 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.
- Background: PubMed 7714424Peters 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.
- Background: PubMed 10530156Petersson 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent and ethics approval did not include public data sharing, and the dataset contains potentially identifiable clinical information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayca Yilmaz, Assoc. Prof. study director
Istanbul University
Ecem Erden Bozdağ principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Disease and Pulp Necrosis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive values of pulp sensibility tests for pulp vitality (time frame: Periprocedural (during pulp testing and access cavity preparation on Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434622, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.