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Completed

NCT Number: NCT06936553

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırıkkale University Faculty of Dentistry

Kirikkale, 71450, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. IL-8, FGF-1 and VEGF expression levels in dentinal fluid, GCF and pulp tissue samples

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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