Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Point of Care Test.
- Who it may be relevant to
- Registry conditions: Apical Periodontitis. Basic parameters: 17 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Agreement of Human Interleukin-6 Chairside Point-of-Care Test (PoCT) to Enzyme-Linked Immunosorbent Assay (ELISA) in Teeth with Apical Periodontitis
Overview
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.
Interventions
- Device Point of Care Test
PoCT as a chairside test, ELISA as a gold standard
Primary outcome measures
- Detect the IL-6 in the exudate of the tooth with apical periodontitis [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- Patient having single root tooth with AP that is negative to the pulp sensitivity test
- Presence of periapical lesion
Exclusion criteria
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Malaysia · 1 center
- Manipal University College Malaysia — Malacca
Identifiers
NCT: NCT06701266 · MUCM/005D/11/2024