Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Study Overview
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Brief Summary
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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
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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

Official Title
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Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Conditions
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Periodontal Pocket, Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease, Endodontic Inflammation, Periodontal Inflammation, Periodontal Attachment Loss, Periodontal Bone Loss, Periodontitis

Intervention / Treatment
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* Diagnostic Test: Orthopantomogram X-ray view
* Diagnostic Test: Endo-Ice
* Diagnostic Test: Electric Pulp Tester (EPT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Patients<br>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<br>* taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification<br>Diagnostic Test: Endo-Ice<br>* Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.<br>Diagnostic Test: Electric Pulp Tester (EPT)<br>* Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).<br>|
| Active Comparator: Periodontitis Patients<br>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<br>* taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification<br>Diagnostic Test: Endo-Ice<br>* Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.<br>Diagnostic Test: Electric Pulp Tester (EPT)<br>* Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).<br>|

What is the study measuring?
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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? | 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? | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Endodontic, Endo ice, Electric Pulp Tester (EPT).