Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Sponsor
Qassim University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04399135
Collaborator
(none)
30
1
2
27.8
1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Orthopantomogram X-ray view
  • Diagnostic Test: Endo-Ice
  • Diagnostic Test: Electric Pulp Tester (EPT)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket
Actual Study Start Date :
Feb 25, 2020
Anticipated Primary Completion Date :
Feb 25, 2022
Anticipated Study Completion Date :
Jun 20, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test? [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.

  2. Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "electrical" test? [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qassim University, Medical City, Dental Clinics Buraydah Qassim Saudi Arabia

Sponsors and Collaborators

  • Qassim University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Bader Alharbi, Principal Investigator, Qassim University
ClinicalTrials.gov Identifier:
NCT04399135
Other Study ID Numbers:
  • # EA/F-2019-3005
First Posted:
May 22, 2020
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
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
Keywords provided by Bader Alharbi, Principal Investigator, Qassim University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2021