Accuracy of Host-derived Biomarkers in Diagnosing Symptomatic and Asymptomatic Apical Periodontitis

NCT ID: NCT06187324

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2024-01-30

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…

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

periopaper

periopaper used to collect GCF

Group Type: EXPERIMENTAL

biomarkers

Intervention Type: DIAGNOSTIC_TEST

by th use of perio paper GCF was collected and Biomarkers level was estimated

Interventions

biomarkers

by th use of perio paper GCF was collected and Biomarkers level was estimated

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Zeena Tariq Abdulhadi

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarhang Hama, PHD

Role: STUDY_DIRECTOR

University of Sulaymania

Locations

Zeena

Baghdad, , Iraq

Countries

Iraq

Central Contacts

zeena AlAni, MSC

Role: CONTACT

zeenaalani@yahoo.com

009647807293326

Anas Mahdi, PHD

Role: CONTACT

a.f.mahdee@gmail.com

Other Identifiers

biomarkers in GCF

Identifier Type: -

Identifier Source: org_study_id