Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis
1 other identifier
interventional
60
1 country
1
Brief 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, 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…
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedFirst Posted
Study publicly available on registry
January 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedJanuary 2, 2024
December 1, 2023
1 month
November 21, 2023
December 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Study Arms (1)
periopaper
EXPERIMENTALperiopaper used to collect GCF
Interventions
by th use of perio paper GCF was collected and Biomarkers level was estimated
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zeena
Baghdad, Iraq
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarhang Hama, PHD
University of Sulaymania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
November 21, 2023
First Posted
January 2, 2024
Study Start
December 30, 2023
Primary Completion
January 30, 2024
Study Completion
January 30, 2024
Last Updated
January 2, 2024
Record last verified: 2023-12