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NCT Number: NCT06701266

Accuracy of PoCT to ELISA by Detecting Human IL-6 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.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manipal University College Malaysia

Malacca, Melaka, 75150, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

Point of Care Test

Device

PoCT as a chairside test, ELISA as a gold standard

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anchu Rachel Thomas

CONTACT

[email protected]

+6011-2729-2297

Sponsors and collaborators

Lead sponsor

Manipal University College Malaysia

Other

Collaborators

  • Melaka Manipal Medical College

Registry information

Official study title

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

Acronym: PoCT ELISA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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