Correlation Between the Clinical Presentation of Pulp and the Biological Mediators in Gingival Crevicular Fluid and the Inflamed Pulpal Tissue (CBCPABMGCFFIPT)

The aim of the present study was to Correlate between the clinical presentation of pulp and the biological mediators in gingival crevicular fluid and the inflamed pulpal tissue.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis (Toothache)
• Intervention / Treatment: Procedure: root canal treatment; Diagnostic test: samples from Gingival crevicular fluid

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 12611
      • AinShams University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

Systemically healthy male and female individuals aged between 18 and 50 years

No physical or mental disabilities

No underlying systemic diseases

Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis with apical periodontitis

Mandibular permanent premolar teeth diagnosed with symptomatic irreversible pulpitis without apical periodontitis

Diagnosis based on the terminology of the American Association of Endodontists (2009)

Patients who provided written informed consent

Fully developed teeth with no previous pulp exposure

Positive response to cold testing

Positive response to electric pulp testing

Exclusion Criteria

Requirement for antibiotic prophylaxis

Diabetes or hematologic disorders

Use of anti-inflammatory drugs, antibiotics, or antidepressants within the previous four weeks

Pregnancy at the time of treatment

Heavy plaque or calculus accumulation

Gingival redness and bleeding

Severe gingivitis or generalized periodontitis

Gingival pocket depths greater than 3 mm

Negative response to sensibility testing (cold test or electric pulp testing)

Presence of apical radiolucency (PAI > 2)

Previously initiated endodontic treatment

Internal or external root resorption

History of trauma

Severe calcific metamorphosis with obliterated root canal spaces on periapical radiographs

Vertical root fractures

Mobility greater than Grade I (Miller's mobility index)

Swelling or sinus tract associated with the treated tooth

Presence of periodontal-endodontic lesions

Teeth that could not be properly isolated with a dental dam

Collection of less than 10 µL of blood from each site

Conflicting clinical and radiographic findings preventing clear group assignment

No bleeding from one or more canal orifices (possible partial necrosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lower premolars; root canal treatment and samples of biomarkers	Procedure: root canal treatment; root canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis; Diagnostic test: samples from Gingival crevicular fluid; samples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth
Active Comparator: control teeth / contralateral tooth; samples of biomarkers	Procedure: root canal treatment; root canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis; Diagnostic test: samples from Gingival crevicular fluid; samples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biological markers level	TNF-alpha and sub P	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score through the Visual analogue scale	where the minimum reading is 0 and the maximum reading is 10	1 week
clinical presentation of irreversible pulpitis	Electric pulp tester	1 week

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): December 5, 2025

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Toothache
• Other Study ID Numbers: 567890111213141516171819202122; Ain Shams University (Registry Identifier: passant abdalla)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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