Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Periodontitis Clinical Trial

Official title:

Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04399135
• Other study ID #: # EA/F-2019-3005
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: April 2021
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 20, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Dental Pulp Diseases
• Endodontic Disease
• Endodontic Inflammation
• Inflammation
• Periodontal Attachment Loss
• Periodontal Bone Loss
• Periodontal Diseases
• Periodontal Inflammation
• Periodontal Pocket
• Periodontitis
• Periodontitis, Localized Aggressive
• Pulpitis

Intervention

Diagnostic Test:
• Orthopantomogram X-ray view
taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
• Endo-Ice
Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
• Electric Pulp Tester (EPT)
Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).

Locations

Country	Name	City	State
Saudi Arabia	Qassim University, Medical City, Dental Clinics	Buraydah	Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (7)

Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. Review. — View Citation

Bender IB. Reversible and irreversible painful pulpitides: diagnosis and treatment. Aust Endod J. 2000 Apr;26(1):10-4. — View 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. — View 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. — View Citation

Rotstein I, Simon JH. Diagnosis, prognosis and decision-making in the treatment of combined periodontal-endodontic lesions. Periodontol 2000. 2004;34:165-203. Review. — View 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

Villa-Chávez CE, Patiño-Marín N, Loyola-Rodríguez JP, Zavala-Alonso NV, Martínez-Castañón GA, Medina-Solís 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.