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Trial record 20 of 83805 for:    testing

Evaluation of Three Pulp Vitality Tests

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ClinicalTrials.gov Identifier: NCT02636504
Recruitment Status : Not yet recruiting
First Posted : December 21, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment
Dental Pulp Diseases Dental Pulp Vitality Testing Device: Laser Doppler Flowmetry

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Three Pulp Vitality Tests
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Device: Laser Doppler Flowmetry
    Pulp vitality of teeth is tested with three pulp vitality testing including laser Doppler flowmetry, cold testing, and electric pulp testing.
    Other Names:
    • Cold testing
    • Electric Pulp Testing


Primary Outcome Measures :
  1. The number of teeth showing the true positive, true negative, false positive, and false negative after pulp vitality testing [ Time Frame: 1 year ]
    Patients who present to the endodontic clinic for a consultation visit prior to treatment. The patient will have three types of pulp vitality tests done on the tooth that is to receive endodontic treatment. The number of teeth that show the true positive, true negative, false positive, and false negative after pulp vitality testing will be measured. For example, a tooth that is diagnosed nonvital based on the pulp vitality testing will be confirmed when endodontic treatment is performed. If there is a discrepancy, it can be counted as false negative. When a tooth is diagnosed vital based on the pulp testing and confirmed to be vital, it can be counted as true positive. When a tooth is diagnosed vital based on the pulp testing and confirmed to be nonvital, it can be counted as false positive. When a tooth is diagnosed nonvital and confirmed novital, it is counted as true negative.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients that need endodontic treatment will have a consultation visit first. In most cases, the endodontic treatment will be provided at a subsequent visit. In some cases the endodontic treatment will be provided at the same visit. Patients who present to the endodontic clinic for a consultation visit for endodontic treatment. The patient will have three types of pulp vitality tests done on the tooth that is to receive endodontic treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636504


Contacts
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Contact: Sahng G Kim, DDS, MS 212-305-2015 sgk2114@cumc.columbia.edu
Contact: Anshul Mainkar, BS aam2207@cumc.columbia.edu

Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Sahng G Kim, DDS, MS Columbia University College of Dental Medicine

Publications:
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02636504     History of Changes
Other Study ID Numbers: AAAO5900
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Columbia University:
Pulp vitality
Pulp testing

Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases