Comparison of IL-8, FGF-1 and VEGF Levels in Pulpal Tissue, GCF and Dentinal Fluid Samples of Healthy, Reversible and Irreversible Pulpitis Diagnosed Teeth

This study will include 51 patients diagnosed with healthy, reversible and irreversible pulpitis. IL-8, FGF-1 and VEGF levels will be compared using pulpal tissue, gingival crevicular fluid, dentinal fluid samples collected from the teeth of these patients. First, the DOS sample will be collected non-invasively using periopaper strips without local anesthesia. Then, the caries will be cleaned by applying local anesthesia and rubber dam to the patient and a dentinal fluid sample will be collected noninvasively using PVDF membranes. In teeth with pulp exposure due to caries, the pulp tissue that needs to be removed will not be disposed of but collected as a sample. Routine root canal treatment procedures will then continue and treatment of the teeth will be completed. The collected samples will be analyzed for IL-8, FGF-1 and VEGF levels by ELISA test.

Study Overview

• Status: Completed
• Conditions: Biomarkers; Pulpitis; Reversible Pulpitis; Pulp Inflammation; Healthy Pulp

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kırıkkale, Turkey (Türkiye), 71450
    • Kırıkkale University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients aged between 16-60 years who presented to Kırıkkale University, Faculty of Dentistry, Department of Endodontics with the indication of root canal treatment and were diagnosed with healthy pulp status (Group 1), symptomatic irreversible pulpitis (Group 2) and asymptomatic reversible pulpitis (Group 3).

Description

Inclusion Criteria:

Control group:

• Unrestored, caries-free vital teeth with healthy pulp
• Orthodontically indicated teeth for extraction
• wisdom teeth indicated for extraction in terms of oral hygiene
• teeth that require root canal treatment for prosthetic purposes

Reversible pulpitis group:

• Teeth that react mildly to cold, hot, sour or sweet stimuli
• Teeth with no history of spontaneous pain
• Teeth that respond to cold test and electric pulp test within normal limits
• Teeth that are not sensitive to chewing or percussion

Irreversible pulpitis group:

• Teeth with a history of continuous moderate or severe spontaneous pain
• Teeth sensitive to percussion
• Teeth without periapical pathology

Exclusion Criteria:

• Patients requiring antibiotic prophylaxis.
• Patients with diabetes or haematological diseases.
• Patients who have used antibiotics or anti-inflammatory drugs in the last three weeks.
• Patients who are pregnant during treatment.
• Patients with intense plaque and tartar on their teeth, redness and bleeding in the gums.
• Patients with severe gingivitis, generalised periodontitis or periodontal pocket depth of more than 3 mm.
• Patients with no response to pulp sensitivity tests, presence of sinus tract, presence of periapical pathology on radiography.
• Teeth without pulp exposure after caries removal

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy pulp group
Irreversible pulpitis group
Reversible pulpitis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-8, FGF-1 and VEGF expression levels in dentinal fluid, GCF and pulp tissue samples	IL-8, FGF-1 and VEGF levels will be measured in dentinal fluid, GCF and pulp tissue samples obtained during routine root canal treatment. The analysis will be performed using ELISA. The aim is to compare expression levels between patients with healthy pulp, reversible pulpitis and irreversible pulpitis.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation analysis between IL-8, FGF-1 and VEGF levels in dentinal fluid, GCF and pulp tissue samples	The study will evaluate the correlation between IL-8, FGF-1 and VEGF concentrations within and between healthy individuals, reversible pulpitis and irreversible pulpitis groups. Correlation analyses will be conducted separately for each group and comparatively between groups using appropriate statistical methods to investigate the relationships between biomarkers in pulp tissue, dentinal fluid and GCF samples.	Day 1

Collaborators and Investigators

• Sponsor: Kırıkkale University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: VEGF; pulpitis; IL-8; FGF-1; pulpal diagnosis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis
• Other Study ID Numbers: 2024/149

Drug and device information, study documents

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