Periodontitis, Localized AggressiveNCT04399135

Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

A study testing Orthopantomogram X-ray view, Endo-Ice and Electric Pulp Tester (EPT) in people with Periodontitis, Localized Aggressive and Periodontal Diseases, run by Qassim University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease
What is being tested?: Orthopantomogram X-ray view, Endo-Ice and Electric Pulp Tester (EPT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSaudi Arabia
Study dates: 25 Feb 2020to 20 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

Qassim University, Medical City, Dental Clinics
Buraidah, Al-Qassim Region

Other trials in Saudi Arabia

About this study

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

Conditions: Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease, Endodontic Inflammation, Periodontal Pocket, Periodontal Inflammation
Being tested: Orthopantomogram X-ray view, Endo-Ice, Electric Pulp Tester (EPT)
Keywords: Periodontitis, Endodontic, Endo ice, Electric Pulp Tester (EPT).
Medical subject headings: Periodontitis, Periodontal Diseases, Dental Pulp Diseases, Pulpitis, Periodontal Pocket, Periodontal Attachment Loss, Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Orthopantomogram X-ray viewDiagnostic test
taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
Endo-IceDiagnostic test
Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
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).

Study groups in NCT04399135
Study group	Role	What they receive
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 Receives: Diagnostic Test: Orthopantomogram X-ray view; Diagnostic Test: Endo-Ice; Diagnostic 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. Receives: Diagnostic Test: Orthopantomogram X-ray view; Diagnostic Test: Endo-Ice; Diagnostic Test: Electric Pulp Tester (EPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: through study completion, an average of 10 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 202020 Jun 2022

First posted22 May 2020
Study start25 Feb 2020
Primary completion25 Feb 2022 (estimated)
Study completion20 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Periodontitis, Localized AggressiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04399135
Sponsor's protocol ID: # EA/F-2019-3005
Status last verified: Apr 2021
First submitted: 9 May 2020
Last updated: 9 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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 at a glance

From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket
ClinicalTrials.gov ID: NCT04399135
Acronym / sponsor ID: # EA/F-2019-3005
Conditions: Periodontitis, Localized Aggressive, Periodontal Diseases, Endodontic Disease, Endodontic Inflammation, Periodontal Pocket, Periodontal Inflammation
Keywords: Periodontitis, Endodontic, Endo ice, Electric Pulp Tester (EPT).
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Qassim UniversityUniversity, hospital or other
Study start: 25 Feb 2020 (actual)
Primary completion: 25 Feb 2022 (estimated)
Study completion: 20 Jun 2022 (estimated)
First posted: 22 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket.

Upon accessing the tooth, no bleeding was counted as necrotic and any presence of blood was counted as a vital pulp

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Normal Patients	Active comparator	Diagnostic Test: Orthopantomogram X-ray view, Diagnostic Test: Endo-Ice, Diagnostic Test: Electric Pulp Tester (EPT)All patients admitted to Qassim dental clinics, who need root canal treatment would be screened for possible involvement in this study
Periodontitis Patients	Active comparator	Diagnostic Test: Orthopantomogram X-ray view, Diagnostic Test: Endo-Ice, Diagnostic Test: Electric Pulp Tester (EPT)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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Orthopantomogram X-ray viewtaking an X-ray to determine bone loss level and attachment loss level for periodontitis classification	Diagnostic test	Normal Patients, Periodontitis Patients
Endo-IceIncluded teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.	Diagnostic test	Normal Patients, Periodontitis Patients
Electric Pulp Tester (EPT)Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).	Diagnostic test	Normal Patients, Periodontitis Patients

Primary outcome

Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test?
Time frame: through study completion, an average of 10 months.
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.
Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "electrical" test?
Time frame: through study completion, an average of 10 months.
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
Background: PubMed 11359291Bender 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.
Background: PubMed 14717862Rotstein 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.
Background: PubMed 10863370Armitage 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.
Background: PubMed 29926951Papapanou 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.
Results publication: PubMed 23880259Villa-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.
Results publication: PubMed 24565651Jespersen 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.
Results publicationVelitchka 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

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Is deep periodontal pocket affects pulp response, therefore, affects the accuracy of pulp test using "thermal" test? (time frame: through study completion, an average of 10 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04399135, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.