CClinicalTrials.gg
CompletedNCT06936553Updated Dec 5, 2025

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

An observational study in Pulpitis, Pulp Inflammation and Healthy Pulp, sponsored by Kırıkkale University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Kırıkkale University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
51
Ages
16 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulpitis
  • Pulp Inflammation
  • Healthy Pulp
  • Biomarkers
  • Reversible Pulpitis

Browse trials for

Keywords

  • pulpal diagnosis
  • VEGF
  • pulpitis
  • FGF-1
  • IL-8
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 51 is below the median of 90 across 21 observational studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Kırıkkale University is the lead sponsor of 112 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
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).

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy pulp group
  • Irreversible pulpitis group
  • Reversible pulpitis group
06

What researchers measure

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.

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

07

Study locations

1 site
  • Kırıkkale University Faculty of Dentistry
    Kirikkale, 71450, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06936553
Lead sponsor
Kırıkkale University
Responsible party
Ali Erdemir (Professor doctor, Kırıkkale University) — Principal investigator
First posted
Apr 20, 2025
Start date
Mar 3, 2025
Primary completion
Sep 3, 2025
Completion
Oct 3, 2025
Last update
Dec 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion