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Status unknownNCT04399135Updated Apr 9, 2021

Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

An interventional study of Orthopantomogram X-ray view and Endo-Ice in Periodontitis, Localized Aggressive, Periodontal Diseases and Endodontic Disease, sponsored by Qassim University. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Qassim University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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).
03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's planned enrollment of 30 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Qassim University is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Normal Patients

    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 · Diagnostic Test: Endo-Ice · Diagnostic Test: Electric Pulp Tester (EPT)

  • Active comparator
    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.

    Diagnostic Test: Orthopantomogram X-ray view · Diagnostic Test: Endo-Ice · Diagnostic Test: Electric Pulp Tester (EPT)

Interventions

  • Diagnostic testOrthopantomogram X-ray view

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

  • Diagnostic testEndo-Ice

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

  • Diagnostic testElectric Pulp Tester (EPT)

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 10 months.

  2. 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.

    Time frame: through study completion, an average of 10 months.

07

Study locations

1 site
  • Qassim University, Medical City, Dental Clinics
    Buraydah, Qassim, Saudi Arabia
08

References and documents

Publications

  • 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. PubMed 11359291 ↗
  • 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. PubMed 14717862 ↗
  • 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. PubMed 10863370 ↗
  • 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. PubMed 29926951 ↗
  • 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. PubMed 23880259 ↗
  • 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. PubMed 24565651 ↗
  • 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

Study documents

  • Informed consent form · Feb 25, 2020

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04399135
Lead sponsor
Qassim University
Responsible party
Bader Alharbi (Principal Investigator, Qassim University) — Principal investigator
First posted
May 22, 2020
Start date
Feb 25, 2020
Primary completion
Feb 25, 2022 (estimated)
Completion
Jun 20, 2022 (estimated)
Last update
Apr 9, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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