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

NCT07289074 | Not Yet Recruiting

• 1 other identifier: Hadeer Mostafa -14422022580639
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis With Apical Peridontitis

Keywords

Gingival crevicular fluid; Matrix Metalloproteinase 9; Neurokinin A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

  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)..

Study Arms (2)

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 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

Interventions

Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth DIAGNOSTIC_TEST

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.

Also known as: 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

Patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical peridontitis; The healthy contralateral teeth of tha same patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadeer Mostafa El Mohamady El Feky: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location

Study Officials

• Saied M Abdel Aziz, Professor of Endodontics

  Faculy of Dentistry, Cairo university, Egypt

  STUDY DIRECTOR

Central Study Contacts

Hadeer M El Mohamady El Feky, BDS, MSc, PhD Candidate

CONTACT

+201029997864; hadeer.elmohamady@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate at Faculty of Dentistry- Endodontic Department (Cairo univerity)

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)