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Evaluation of Three Pulp Vitality Tests

NCT ID: NCT02636504

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.

Detailed Description

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Prior to starting any endodontic treatment, it is essential to determine the vitality of the tooth in question. Vitality of a tooth is defined as the presence of blood flow into the tooth. The vitality status of a tooth will affect the success of endodontic treatment, and therefore plays an important role in treatment planning. Two established methods of determining vitality are electric pulp tests and cold tests. However, both these methods have drawbacks. Both methods use the presence of sensory feedback in the tooth as a predictor of tooth vitality. This can lead to errors because blood flow and nerves in the tooth may be lost at different times, resulting in false-positive and false-negative responses. Both are subjective and patient-dependent, relying on the patient to indicate when pain is felt. In addition, studies have suggested that electric pulp testing and cold tests are not as reliable in immature teeth, teeth undergoing orthodontic movement, traumatized teeth, and teeth with significant secondary dentin. Laser Doppler flowmetry is a technique that utilizes the Doppler principle to determine blood flow. It has been used widely in the medical field to measure blood flow in the skin. Some studies have also shown good results in measuring blood flow in the pulp of teeth. The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.

Conditions

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Dental Pulp Diseases Dental Pulp Vitality Testing

Keywords

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Pulp vitality Pulp testing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Laser Doppler Flowmetry

Pulp vitality of teeth is tested with three pulp vitality testing including laser Doppler flowmetry, cold testing, and electric pulp testing.

Intervention Type DEVICE

Other Intervention Names

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Cold testing Electric Pulp Testing

Eligibility Criteria

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Inclusion Criteria

* Criteria for inclusion in the study will be that the individual has teeth that require endodontic treatment and patient is willing to undergo two additional vitality tests which will take about 20 minutes of additional time.

Exclusion Criteria

* No group of special subjects or vulnerable population is being targeted in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sahng G Kim, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University College of Dental Medicine

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sahng G Kim, DDS, MS

Role: CONTACT

Phone: 212-305-2015

Email: [email protected]

References

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Karayilmaz H, Kirzioglu Z. Comparison of the reliability of laser Doppler flowmetry, pulse oximetry and electric pulp tester in assessing the pulp vitality of human teeth. J Oral Rehabil. 2011 May;38(5):340-7. doi: 10.1111/j.1365-2842.2010.02160.x. Epub 2010 Sep 26.

Reference Type BACKGROUND
PMID: 20868433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22099893 (View on PubMed)

Other Identifiers

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AAAO5900

Identifier Type: -

Identifier Source: org_study_id