Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis

Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis: A Comparative Cross Sectional Study

The aim of this study is to investigate the levels Neurokinin A and of Matrix Mtalloproteinase (MMP-9) in gingival crevicular fluid samples (GCF) as potential biomarkers for the diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis and to correlate the level of these diagnostic biomarkers ( Nerokinin A and MMP-9) with the pre-operative pain severity using the Numerical Rating Scale (NRS).

This study will utilize a comparative cross-sectional design to assess the levels of Neurokinin A (NKA) and Matrix metalloproteinase-9 (MMP-9) in gingival crevicular fluid (GCF) samples from symptomatic and healthy contralateral teeth with normal pulp.

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Irreversible Pulpitis With Apical Peridontitis
• Intervention / Treatment: Diagnostic test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth

Detailed Description

The study design is Comparative Cross sectional study. The study will be conducted at the Dental hospital of Cairo University with access to patients undergoing treatment for teeth with pulpitis and apical periodontitis.

• Study Type: Observational
• Enrollment (Estimated): 23

Contacts and Locations

• Study Contact: Name: Hadeer M EL Mohamady EL Feky, BDS, MSc, PhD Candidate; Phone Number: +201029997864; Email: hadeer.elmohamady@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11553
      • Faculty of Dentistry, Cairo University
      • Contact: Hadeer M EL Mohamady EL Feky, BDS, MSc, PhD Candidate; Phone Number: +201029997864; Email: hadeer.elmohamady@dentistry.cu.edu.eg
      • Principal Investigator: Hadeer M El mohamady El Feky, BDS, MSc, PhD Candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults (aged 18-60) diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis and have their healthy contralateral teeth with normal pulp with clinically healthy periodontium and not undergone any previous treatments in the involved teeth.

Description

Inclusion Criteria:

• Adults (aged 18-60) diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis and have healthy contralateral teeth with normal pulp.
• The involved teeth should have healthy periodontal conditions (Normal periodontal pocket depth, No bleeding on Probing and No mobility).
• Patients who have not undergone any previous dental treatments in the involved teeth.
• Signed informed consent.

Exclusion Criteria:

• Patients with systemic diseases affecting the immune response (e.g., autoimmune diseases, uncontrolled diabetes).
• Patients taking medications that can affect the inflammatory markers (e.g., Steroids and Tetracyclins).
• Smokers.
• Individuals with periodontal disease unrelated to apical periodontitis.
• Presence of marginal bone loss.
• Pregnant women.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical peridontitis; Gingival crevicular fluid samples will be collected from the symptomatic teeth and from the healthy contalateral teeth with normal pulp to detect the lavel of Neurokinin A (NKA) and Matrix metalloproteinase-9 (MMP-9) in the diseased teeth and compare it with that of the healthy teeth.; The study will also correlate the level of these biomarkers with the preoperative pain severity using the Numerical Rating Scale (NRS).	Diagnostic test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth; The detection of the inflammatory biomarkers levels in the gingival crevicular fluid of the symptomatic teeth is considered an objective,molecular-based and non invasive method for diagnosis.; Other Names: Matrix Metalloproteinase 9 and Neurokinin A will be detected in gingival crevicular fluid samples by using ELISA kits; correlate the level of these diagnostic biomarkers with the pre-operative pain severity by using the numerical rating scale
The healthy contralateral teeth of tha same patients; Gingival crevicular fluid samples will be collected from the symptomatic teeth and from the healthy contalateral teeth to detect the lavel of Neurokinin A (NKA) and Matrix metalloproteinase-9 (MMP-9) in the diseased teeth and compare it with that of the healthy contralateral teeth.; The study will also correlate the level of these biomarkers and the preoperative pain severity using the Numerical Rating Scale (NRS).	Diagnostic test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth; The detection of the inflammatory biomarkers levels in the gingival crevicular fluid of the symptomatic teeth is considered an objective,molecular-based and non invasive method for diagnosis.; Other Names: Matrix Metalloproteinase 9 and Neurokinin A will be detected in gingival crevicular fluid samples by using ELISA kits; correlate the level of these diagnostic biomarkers with the pre-operative pain severity by using the numerical rating scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of Neurokinin A in gingival crevicular fluid samples of teeth diagnosed with symptomatic irreversible pulpitis with symptomatic apical peridontitis and the contralateral teeth with healthy normal pulp.	Method of Measurement: Human Neurokinin A ELISA Kit (Bioassay Technology Laboratory, Shanghai, China) - Unit of measurement: Pg/ml	Pre-operative measurement for Neurokinin A in gingival crevicular fluid samples

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A- The level of MMP-9 in gingival crevicular fluid samples of the symptomatic teeth and the contralateral teeth with normal pulp. B- The pre-operative pain severity in relation with the levels of these diagnostic biomarkers (Nerokinin A and MMP-9).	Methods of measurement: A- Human Matrix Metalloproteinase 9;Gelatinase B- ELISA Kit: (Bioassay Technology Laboratory, Shanghai, China) - Unit of measurement: Pg/ml B- The Numerical Rating Scale (NRS): is a commonly used tool for assessing pain severity and consists of a line (either vertical or horizontal) divided into 11 numbers ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain - Unit of measurement: Score (0-10)	A- Pre-operative measurement for Matrix Metalloproteinase 9 in gingival crevicular fluid samples. B- Pre-operative pain severity assessment to corelate it with the levels of these diagnostic biomarkers (Nerokinin A and MMP-9)..

Collaborators and Investigators

• Sponsor: Hadeer Mostafa El Mohamady El Feky
• Investigators: Study Director: Saied M Abdel Aziz, Professor of Endodontics, Faculy of Dentistry, Cairo university, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Gingival crevicular fluid; Matrix Metalloproteinase 9; Neurokinin A
• Other Study ID Numbers: Hadeer Mostafa -14422022580639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No