Apical PeriodontitisPoCT ELISANCT06701266
Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis
An observational study of Apical Periodontitis, run by Manipal University College Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Point of Care Test
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who is having apical periodontitis and undergo RCT in MUCM
Who may be able to join
- Patient having single root tooth with AP that is negative to the pulp sensitivity test
- Presence of periapical lesion
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Point of Care Test
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care TestDevice
PoCT as a chairside test, ELISA as a gold standard
| Study group | Role | What they receive |
|---|---|---|
| Patient have apical periodontitis | Patient have single rooted tooth with apical periodontitis that undergo RCT in MUCM. Receives: Device: Point of Care Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manipal University College Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Melaka Manipal Medical College
- Responsible party
- Principal investigator, Dr. Anchu Rachel Thomas, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701266
- Sponsor's protocol ID
- MUCM/005D/11/2024
- Acronym
- PoCT ELISA
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06701266
- Acronym / sponsor ID
- PoCT ELISA / MUCM/005D/11/2024
- Conditions
- Apical Periodontitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manipal University College MalaysiaUniversity, hospital or other
- Collaborators
- Melaka Manipal Medical College
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient have apical periodontitis | – | Device: Point of Care TestPatient have single rooted tooth with apical periodontitis that undergo RCT in MUCM. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who is having apical periodontitis and undergo RCT in MUCM
Key inclusion criteria (2 listed)
- Patient having single root tooth with AP that is negative to the pulp sensitivity test
- Presence of periapical lesion
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care TestPoCT as a chairside test, ELISA as a gold standard | Device | Patient have apical periodontitis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis, run by Manipal University College Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anchu Rachel Thomas (+6011-2729-2297, rachel.thomas@manipal.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the IL-6 in the exudate of the tooth with apical periodontitis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.