Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis (PoCT ELISA)

November 20, 2024 updated by: Dr. Anchu Rachel Thomas, Manipal University College Malaysia

Diagnostic Agreement of Human Interleukin-6 Chairside Point-of-Care Test (PoCT) to Enzyme-Linked Immunosorbent Assay (ELISA) in Teeth with Apical Periodontitis

To compare the diagnostic agreement of human IL-6 chairside PoCT to ELISA in apical periodontitis undergoing endodontic therapy which could be clinically helpful to monitor the healing of periapical tissues enabling the clinician to complete the endodontic procedure, leading to a better patient care.

This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves 30 selected patients who have single rooted tooth with apical periodontitis that undergo RCT. The collection of the exudate from the canal will be on pre and post-instrumentation. The exudated will collect twice in each instrumentation for PoCT and ELISA.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Melaka
      • Malacca, Melaka, Malaysia, 75150
        • Manipal University College Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient who is having apical periodontitis and undergo RCT in MUCM

Description

Inclusion Criteria:

  • Patient having single root tooth with AP that is negative to the pulp sensitivity test
  • Presence of periapical lesion

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient have apical periodontitis
Patient have single rooted tooth with apical periodontitis that undergo RCT in MUCM.
Device: Point of Care Test
PoCT as a chairside test, ELISA as a gold standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect the IL-6 in the exudate of the tooth with apical periodontitis
Time Frame: 1 week
Collection of exudate in Pre-instrumentation for PoCT and ELISA . After 1 week, collection of exudate in post-instrumentation for PoCT and ELISA will be done.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manipal University College Malaysia

Collaborators

Melaka Manipal Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUCM/005D/11/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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