BiomarkersNCT06187324
Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis
A study testing biomarkers in people with Biomarkers, run by University of Baghdad at 1 site in Iraq.
Trial summary
Apical lesions usually present clinically as a chronic infection, remaining as asymptomatic apical periodontitis(AAP). Because the balance among inflammation and bacteria is a dynamic process, AAP may undergo an acute exacerbation and become symptomatic, presenting as symptomatic apical periodontitis or acute abscess… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- What is being tested?
- biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 30 Dec 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systematically healthy individuals with healthy periodontal status which can be detected by periodontal probing depth (PPD) and bleeding on probing (BOP).
- Both sexes and ages between 25-45 years old will be targeted.
- Patients with one or more SAP or AAP teeth will be included within this study.
- The involved tooth or teeth have to be one or both of the maxillary premolars either In one or both sides.
- Selected SAP and AAP has to be without periodontal diseases.
Who cannot join
- Systematically unhealthy individuals or those who consumed any treatment that may affect periodontal condition.
- Consumption of antibiotics within 3-months prior to the study first examination.
- Periodontitis.
- Smoker.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Anas Mahdi, PHD contact
About this study
Official title: Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis and Predicting the Outcome of Endodontic Treatment: Controlled Clinical Trial
Apical lesions usually present clinically as a chronic infection, remaining as asymptomatic apical periodontitis(AAP). Because the balance among inflammation and bacteria is a dynamic process, AAP may undergo an acute exacerbation and become symptomatic, presenting as symptomatic apical periodontitis or acute abscess, or it may evolve from the acute to the chronic stage. Identification of specific biomarker could help in establishing more accurate diagnosis. Biological marker serves as a parameter that is indicative of underlying physiology and health of the tissue. It is measurable as well as quantifiable. The aim of this study: To assess the level of potential biomarkers in asymptomatic and symptomatic apical Periodontitis, and to determine the prediction potential of the same biomarkers for the outcome of endodontic treatment after 1year recall…
Read the detailed description
Participants will be selected from patients attending the Restorative and Aesthetic Department in the College of Dentistry University of Baghdad. Consent form will be assigned with all participants prior to the study to take their agreement for participation. Also case sheet including all diagnostic procedures will be prepared and used with all cases. The involved tooth should not have more than 3 surfaces affected with caries including mesioocclusal(M0), distoocclusal(DO) or mesio occlusodistal( MOD). Cone beam computed tomography (CBCT) will be taken for the accused teeth. Gingival crevicular fluid(GCF) samples will be collected from the gingival sulcus of the test and healthy teeth within the same participant. The GCF samples will be centrifuged at 400-500 g for 4-5 min and Concentrations of Matrix metaloproteinases(MMP8), Tissue inhibitor(TIMP1),receptor activator of nuclear factor kappa-B(RANK), RANK ligand(RANKL) andosteoprotegerin( OPG) will be determined using ELISA test.
- Conditions
- Biomarkers
- Being tested
- biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkersDiagnostic test
by th use of perio paper GCF was collected and Biomarkers level was estimated
| Study group | Role | What they receive |
|---|---|---|
| periopaper | Experimental | periopaper used to collect GCF Receives: Diagnostic Test: biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the level of host-derived biomarkers (RANK,RANKL,OPG,MMP8,TIMP1)in asymptomatic and symptomatic apical periodontitis and their ability to predict the outcome of endodontic treatment: controlled clinical trial
mesearing level of biomarkers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start30 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- two groups comparison,symptomatic and asymptomatic
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeena Tariq Abdulhadi, University of Baghdad
- Investigators
- Sarhang Hama, PHD, Study director, University of Sulaymania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187324
- Sponsor's protocol ID
- biomarkers in GCF
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis and Predicting the Outcome of Endodontic Treatment: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06187324
- Acronym / sponsor ID
- biomarkers in GCF
- Conditions
- Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 2 Jan 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.
Apical lesions usually present clinically as a chronic infection, remaining as asymptomatic apical periodontitis(AAP). Because the balance among inflammation and bacteria is a dynamic process, AAP may undergo an acute exacerbation and become symptomatic, presenting as symptomatic apical periodontitis or acute abscess, or it may evolve from the acute to the chronic stage. Identification of specific biomarker could help in establishing more accurate diagnosis. Biological marker serves as a parameter that is indicative of underlying physiology and health of the tissue. It is measurable as well as quantifiable. The aim of this study: To assess the level of potential biomarkers in asymptomatic and symptomatic apical Periodontitis, and to determine the prediction potential of the same biomarkers for the outcome of endodontic treatment after 1year recall…
Detailed description
Participants will be selected from patients attending the Restorative and Aesthetic Department in the College of Dentistry University of Baghdad. Consent form will be assigned with all participants prior to the study to take their agreement for participation. Also case sheet including all diagnostic procedures will be prepared and used with all cases. The involved tooth should not have more than 3 surfaces affected with caries including mesioocclusal(M0), distoocclusal(DO) or mesio occlusodistal( MOD). Cone beam computed tomography (CBCT) will be taken for the accused teeth. Gingival crevicular fluid(GCF) samples will be collected from the gingival sulcus of the test and healthy teeth within the same participant. The GCF samples will be centrifuged at 400-500 g for 4-5 min and Concentrations of Matrix metaloproteinases(MMP8), Tissue inhibitor(TIMP1),receptor activator of nuclear factor kappa-B(RANK), RANK ligand(RANKL) andosteoprotegerin( OPG) will be determined using ELISA test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two groups comparison,symptomatic and asymptomatic
| Arm | Type | Receives |
|---|---|---|
| periopaper | Experimental | Diagnostic Test: biomarkersperiopaper used to collect GCF |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systematically healthy individuals with healthy periodontal status which can be detected by periodontal probing depth (PPD) and bleeding on probing (BOP).
- Both sexes and ages between 25-45 years old will be targeted.
- Patients with one or more SAP or AAP teeth will be included within this study.
- The involved tooth or teeth have to be one or both of the maxillary premolars either In one or both sides.
- Selected SAP and AAP has to be without periodontal diseases.
Key exclusion criteria (5 listed)
- Systematically unhealthy individuals or those who consumed any treatment that may affect periodontal condition.
- Consumption of antibiotics within 3-months prior to the study first examination.
- Periodontitis.
- Smoker.
- Pregnancy and lactation
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 |
|---|---|---|
| biomarkersby th use of perio paper GCF was collected and Biomarkers level was estimated | Diagnostic test | periopaper |
Primary outcome
Assessment the level of host-derived biomarkers (RANK,RANKL,OPG,MMP8,TIMP1)in asymptomatic and symptomatic apical periodontitis and their ability to predict the outcome of endodontic treatment: controlled clinical trial
Time frame: 1 year
mesearing level of biomarkers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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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. This study is not recruiting at the moment.
Anas Mahdi, PHD contact
Sarhang Hama, PHD study director
University of Sulaymania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biomarkers in people with Biomarkers, run by University of Baghdad at 1 site in Iraq.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jan 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 Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeena AlAni, MSC (009647807293326, zeenaalani@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the level of host-derived biomarkers (RANK,RANKL,OPG,MMP8,TIMP1)in asymptomatic and symptomatic apical periodontitis and their ability to predict the outcome of endodontic treatment: controlled clinical trial (time frame: 1 year). 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 2 Jan 2024.