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Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Primary Purpose

Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Orthopantomogram X-ray view
Endo-Ice
Electric Pulp Tester (EPT)
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontitis, Localized Aggressive focused on measuring Periodontitis, Endodontic, Endo ice, Electric Pulp Tester (EPT).

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Qassim University, Medical City, Dental Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal Patients

Periodontitis Patients

Arm Description

All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2020
Last Updated
April 8, 2021
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT04399135
Brief Title
Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket
Official Title
Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
February 25, 2022 (Anticipated)
Study Completion Date
June 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease, Endodontic Inflammation, Periodontal Pocket, Periodontal Inflammation, Periodontal Attachment Loss, Periodontal Bone Loss, Periodontitis
Keywords
Periodontitis, Endodontic, Endo ice, Electric Pulp Tester (EPT).

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Patients
Arm Type
Active Comparator
Arm Description
All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Arm Title
Periodontitis Patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Orthopantomogram X-ray view
Intervention Description
taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
Intervention Type
Diagnostic Test
Intervention Name(s)
Endo-Ice
Intervention Description
Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electric Pulp Tester (EPT)
Intervention Description
Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).
Primary Outcome Measure Information:
Title
Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test?
Description
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.
Time Frame
through study completion, an average of 10 months.
Title
Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "electrical" test?
Description
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.
Time Frame
through study completion, an average of 10 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Qassim University, Medical City, Dental Clinics
City
Buraydah
State/Province
Qassim
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11359291
Citation
Bender IB. Reversible and irreversible painful pulpitides: diagnosis and treatment. Aust Endod J. 2000 Apr;26(1):10-4. doi: 10.1111/j.1747-4477.2000.tb00144.x.
Results Reference
background
PubMed Identifier
14717862
Citation
Rotstein I, Simon JH. Diagnosis, prognosis and decision-making in the treatment of combined periodontal-endodontic lesions. Periodontol 2000. 2004;34:165-203. doi: 10.1046/j.0906-6713.2003.003431.x. No abstract available.
Results Reference
background
PubMed Identifier
10863370
Citation
Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
Results Reference
background
PubMed Identifier
29926951
Citation
Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
Results Reference
background
PubMed Identifier
23880259
Citation
Villa-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.
Results Reference
result
PubMed Identifier
24565651
Citation
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.
Results Reference
result
Citation
Velitchka Dosseva, Antoaneta Mlachkova and Angela Gusiyska. Evaluation of The Pulp Vitality in Patients With Periodontitis/ Journal of IMAB - Annual Proceeding (Scientific Papers) 2007, vol. 13, book 2, pp.19-20
Results Reference
result

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Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

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