Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Not Applicable

• Conditions: Periodontal Pocket; Endodontic Inflammation; Periodontitis; Endodontic Disease; Periodontal Diseases; Periodontitis, Localized Aggressive; Periodontal Inflammation; Periodontal Attachment Loss; Periodontal Bone Loss
• Interventions: Diagnostic Test: Orthopantomogram X-ray view; Diagnostic Test: Endo-Ice; Diagnostic Test: Electric Pulp Tester (EPT)

• Registration Number: NCT04399135
• Lead Sponsor: Qassim University

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

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-09
• Primary Completion: 2022-02-25
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Patients	Endo-Ice	All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Periodontitis Patients	Endo-Ice	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.
Normal Patients	Orthopantomogram X-ray view	All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Normal Patients	Electric Pulp Tester (EPT)	All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Periodontitis Patients	Electric Pulp Tester (EPT)	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.
Periodontitis Patients	Orthopantomogram X-ray view	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Qassim University, Medical City, Dental Clinics; 🇸🇦 Buraydah, Qassim, Saudi Arabia