Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teet... | NCT06701266

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

NCT06701266

Sponsor

Manipal University College Malaysia

Status

Not yet recruiting

Last Update Posted

Nov 22, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Apical Periodontitis

Interventions

Point of Care Test

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Nov 20, 2024

First Submission Date that Met QC Criteria

Nov 20, 2024

First Posted Date

Nov 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2024

Last Update Posted Date

Nov 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Anchu Rachel Thomas, Associated Professor of Conservative Dentistry & Endodontics, Melaka Manipal Medical CollegePrincipal Investigator

Lead Sponsor

Manipal University College MalaysiaOTHER

Collaborators

Name	Class
Melaka Manipal Medical College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient have apical periodontitis		Patient have single rooted tooth with apical periodontitis that undergo RCT in MUCM.	Device: Point of Care Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Point of Care Test	Device	PoCT as a chairside test, ELISA as a gold standard	Patient have apical periodontitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patient who is having apical periodontitis and undergo RCT in MUCM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anchu Rachel Thomas	Contact	+6011-2729-2297		rachel.thomas@manipal.edu.my

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manipal University College Malaysia		Malacca	Melaka	75150	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010485	Periapical Periodontitis

Ancestor Terms

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided