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

NCT06936553 | Completed

• 1 other identifier: 2024/149
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis; Pulp Inflammation; Healthy Pulp; Biomarkers; Reversible Pulpitis

Keywords

pulpal diagnosis; VEGF; pulpitis; FGF-1; IL-8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation analysis between IL-8, FGF-1 and VEGF levels in dentinal fluid, GCF and pulp tissue samples

  Day 1

Study Arms (3)

Healthy pulp group

Irreversible pulpitis group

Reversible pulpitis group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Gender Eligibility Details: biologically male and female patients
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University Faculty of Dentistry

Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: March 3, 2025
• Primary Completion: September 3, 2025
• Study Completion: October 3, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-04

Locations

TU (1)