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

Not Applicable

Not yet recruiting

• Conditions: Biomarkers
• Interventions: Diagnostic Test: biomarkers

• Registration Number: NCT06187324
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study First Submitted: 2023-11-21
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study Start: 2023-12-30
• Study First Posted: 2024-01-02
• Last Update Posted: 2024-01-02
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
periopaper	biomarkers	periopaper used to collect GCF

Primary Outcome Measures

Name	Time	Method
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	1 year	mesearing level of biomarkers

Trial Locations

Locations (1)

Zeena; 🇮🇶 Baghdad, Iraq