Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

April 8, 2021 updated by: Bader Alharbi, Qassim University
The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket. The null hypothesis is no significant effect of periodontitis on the accuracy of pulp test.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket.

All patients who need root canal treatment would be screened to determine the periodontal condition for possible involvement in this study. They would be grouped into two groups, normal and periodontitis Group.

Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice and electric pulp tester (EPT). Similar or adjacent teeth with no caries, restorations, or a history of the previous injury will be used as controls for that patient.

Upon accessing the tooth, no bleeding was counted as necrotic and any presence of blood was counted as a vital pulp

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Qassim
      • Buraydah, Qassim, Saudi Arabia
        • Qassim University, Medical City, Dental Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients from 18 to 40 years old.
  • Periodontitis grade II, III and IV
  • Non-traumatized teeth.
  • No prior non-surgical root canal treatment (NS RCT).

Exclusion Criteria:

  • Periodontitis grade I.
  • Patients with medically compromising conditions (ASA III and above).
  • Trauma within the last six months.
  • Partially necrotic pulps.
  • Previously endodontically treated or initiation of treatment will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Patients
All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Diagnostic test: Orthopantomogram X-ray view
taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
Diagnostic test: Endo-Ice
Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
Diagnostic test: Electric Pulp Tester (EPT)
Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).
Active Comparator: Periodontitis Patients
All patients who need root canal treatment would be screened to determine the periodontal condition for possible involvement in this study. the periodontitis patients would be categorized according to the new periodontitis classification 2017 world workshop.
Diagnostic test: Orthopantomogram X-ray view
taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
Diagnostic test: Endo-Ice
Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
Diagnostic test: Electric Pulp Tester (EPT)
Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test?
Time Frame: through study completion, an average of 10 months.
Endo-Ice would be used as a thermal test and participants will be asked to lift their hand up if they felt cold and keep it raised until the sensation is gone. Upon accessing the tooth, no bleeding would be counted as necrotic and any presence of blood counted as a vital pulp.
through study completion, an average of 10 months.
Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "electrical" test?
Time Frame: through study completion, an average of 10 months.
For Electrical Pulp tester (EPT) would be used as electrical pulp test. Any response before 80 was recorded as positive. Upon accessing the tooth, no bleeding would be counted as necrotic and any presence of blood counted as a vital pulp.
through study completion, an average of 10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qassim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2020

Primary Completion (Anticipated)

February 25, 2022

Study Completion (Anticipated)

June 20, 2022

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # EA/F-2019-3005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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