NCT04399135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

May 9, 2020

Last Update Submit

April 8, 2021

Conditions

Periodontitis, Localized AggressivePeriodontal DiseasesEndodontic DiseaseEndodontic InflammationPeriodontal PocketPeriodontal InflammationPeriodontal Attachment LossPeriodontal Bone LossPeriodontitis

Keywords

PeriodontitisEndodonticEndo iceElectric Pulp Tester (EPT).

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Normal Patients

ACTIVE COMPARATOR

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 viewDiagnostic Test: Endo-IceDiagnostic Test: Electric Pulp Tester (EPT)

Periodontitis Patients

ACTIVE COMPARATOR

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 viewDiagnostic Test: Endo-IceDiagnostic Test: Electric Pulp Tester (EPT)

Interventions

Orthopantomogram X-ray viewDIAGNOSTIC_TEST

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

Normal PatientsPeriodontitis Patients
Endo-IceDIAGNOSTIC_TEST

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

Normal PatientsPeriodontitis Patients
Electric Pulp Tester (EPT)DIAGNOSTIC_TEST

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

Normal PatientsPeriodontitis Patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qassim University, Medical City, Dental Clinics

Buraidah, Al-Qassim Region, Saudi Arabia

Location

Related Publications (7)

  • 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.

    PMID: 11359291BACKGROUND

  • 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.

    PMID: 14717862BACKGROUND

  • 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.

    PMID: 10863370BACKGROUND

  • 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.

    PMID: 29926951BACKGROUND

  • 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.

    PMID: 23880259RESULT

  • 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.

    PMID: 24565651RESULT

  • 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

    RESULT

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesDental Pulp DiseasesPulpitisPeriodontal PocketPeriodontal Attachment LossAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPeriodontal AtrophyBone ResorptionBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 22, 2020

Study Start

February 25, 2020

Primary Completion

February 25, 2022

Study Completion

June 20, 2022

Last Updated

April 9, 2021

Record last verified: 2021-04

Locations

SA(1)