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

NCT06701266 | Not Yet Recruiting DMC

• 1 other identifier: MUCM/005D/11/2024
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Detect the IL-6 in the exudate of the tooth with apical periodontitis

  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

Study Arms (1)

Patient have apical periodontitis

Patient have single rooted tooth with apical periodontitis that undergo RCT in MUCM.

Device: Point of Care Test

Interventions

Point of Care Test DEVICE

PoCT as a chairside test, ELISA as a gold standard

Patient have apical periodontitis

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who is having apical periodontitis and undergo RCT in MUCM

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Manipal University College Malaysia: lead
• Melaka Manipal Medical College: collaborator

Study Sites (1)

Manipal University College Malaysia

Malacca, Melaka, 75150, Malaysia

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Anchu Rachel Thomas

CONTACT

+6011-2729-2297; rachel.thomas@manipal.edu.my

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of Conservative Dentistry & Endodontics

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)