Symptomatic Irreversible Pulpitis With Apical PeridontitisNCT07289074
Neurokinin A and Matrix Metalloproteinase 9 Levels in Gingival Crevicular Fluid Samples of Teeth With Symptomatic Irreversible Pulpitis With Symptomatic Apical Periodontitis
An observational study of Symptomatic Irreversible Pulpitis With Apical Peridontitis, run by Hadeer Mostafa El Mohamady El Feky at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis With Apical Peridontitis
- What is being tested?
- Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hadeer M El Mohamady El Feky, BDS, MSc, PhD Candidate contact
Egypt1 site
Faculty of Dentistry, Cairo university
Cairo, Cairo Governorate, 11553
Hadeer M EL Mohamady EL Feky, BDS, MSc, PhD Candidate, +201029997864, hadeer.elmohamady@dentistry.cu.edu.eg
Hadeer M El mohamady El Feky, BDS, MSc, PhD Candidate
About this study
Official 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
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.
Read the 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.
- Being tested
- Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth
- Keywords
- Gingival crevicular fluid, Matrix Metalloproteinase 9, Neurokinin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teethDiagnostic test
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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)
Measured: 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)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis With Apical PeridontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadeer Mostafa El Mohamady El Feky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hadeer Mostafa El Mohamady El Feky, Cairo University
- Investigators
- Saied M Abdel Aziz, Professor of Endodontics, Study director, Faculy of Dentistry, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289074
- Sponsor's protocol ID
- Hadeer Mostafa -14422022580639
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07289074
- Acronym / sponsor ID
- Hadeer Mostafa -14422022580639
- Keywords
- Gingival crevicular fluid, Matrix Metalloproteinase 9, Neurokinin A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Hadeer Mostafa El Mohamady El FekyUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical peridontitis | – | Diagnostic Test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth* 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). |
| The healthy contralateral teeth of tha same patients | – | Diagnostic Test: Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teeth* 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival crevicular fluid samples from the symptomatic teeth and the healthy contrlateral teethAlso: 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 scaleThe 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. | Diagnostic test | Patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical peridontitis, The healthy contralateral teeth of tha same patients |
Primary outcome
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
1 secondary outcome
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)..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadeer M El Mohamady El Feky, BDS, MSc, PhD Candidate contact
Saied M Abdel Aziz, Professor of Endodontics study director
Faculy of Dentistry, Cairo university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Irreversible Pulpitis With Apical Peridontitis, run by Hadeer Mostafa El Mohamady El Feky at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeer M El Mohamady El Feky, BDS, MSc, PhD Candidate (+201029997864, hadeer.elmohamady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.