Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

NCT ID: NCT04399135

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2022-06-20

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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal Patients

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

Group Type ACTIVE_COMPARATOR

Orthopantomogram X-ray view

Intervention Type DIAGNOSTIC_TEST

taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification

Endo-Ice

Intervention Type DIAGNOSTIC_TEST

Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.

Electric Pulp Tester (EPT)

Intervention Type DIAGNOSTIC_TEST

Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).

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.

Group Type ACTIVE_COMPARATOR

Orthopantomogram X-ray view

Intervention Type DIAGNOSTIC_TEST

taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification

Endo-Ice

Intervention Type DIAGNOSTIC_TEST

Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.

Electric Pulp Tester (EPT)

Intervention Type DIAGNOSTIC_TEST

Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).

Interventions

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Orthopantomogram X-ray view

taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification

Intervention Type DIAGNOSTIC_TEST

Endo-Ice

Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qassim University

OTHER

Sponsor Role lead

Responsible Party

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Bader Alharbi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qassim University, Medical City, Dental Clinics

Buraidah, Al-Qassim Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type BACKGROUND
PMID: 11359291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14717862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10863370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29926951 (View on PubMed)

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.

Reference Type RESULT
PMID: 23880259 (View on PubMed)

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.

Reference Type RESULT
PMID: 24565651 (View on PubMed)

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

Reference Type RESULT

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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# EA/F-2019-3005

Identifier Type: -

Identifier Source: org_study_id

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