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NCT Number: NCT07289074

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location contact

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

CONTACT

[email protected]

+201029997864

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

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

    Time frame: Pre-operative measurement for Neurokinin A in gingival crevicular fluid samples

    Method of Measurement:

    Human Neurokinin A ELISA Kit (Bioassay Technology Laboratory, Shanghai, China) - Unit of measurement: Pg/ml

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).

    Time frame: 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)..

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+201029997864

Sponsors and collaborators

Lead sponsor

Hadeer Mostafa El Mohamady El Feky

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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