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

NCT07592455 | Completed

• 2 other identifiers: 567890111213141516171819202122Ain Shams University
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis (Toothache)

Outcome Measures

Primary Outcomes (1)

• biological markers level

  TNF-alpha and sub P

  2 months

Secondary Outcomes (2)

• Pain score through the Visual analogue scale

  1 week

• clinical presentation of irreversible pulpitis

  1 week

Study Arms (2)

lower premolars

EXPERIMENTAL

root canal treatment and samples of biomarkers

Procedure: root canal treatment; Diagnostic Test: samples from Gingival crevicular fluid

control teeth / contralateral tooth

ACTIVE COMPARATOR

samples of biomarkers

Procedure: root canal treatment; Diagnostic Test: samples from Gingival crevicular fluid

Interventions

root canal treatment PROCEDURE

root canal treatment for 2 groups , irreversible pulpitis and the other group is irreversible pulpitis with apical periodontitis

control teeth / contralateral tooth; lower premolars

samples from Gingival crevicular fluid DIAGNOSTIC_TEST

samples from the gingival crevicular fluid before and after endodontic treatment and from contralateral tooth

control teeth / contralateral tooth; lower premolars

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams University

Cairo, Cairo Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start: September 28, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 5, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

EG (1)