Clinical trial NCT04399135: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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).
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test?
timeFrame: through study completion, an average of 10 months.
measure: Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "electrical" test?
timeFrame: through study completion, an average of 10 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Buraydah
country: Saudi Arabia
facility: Qassim University, Medical City, Dental Clinics
state: Qassim
Study officials:
References:
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.
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.
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.
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.
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.
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.
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