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, 51 participants, Kırıkkale University

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Registry	NCT06936553
Status	Completed
Study type	Observational
Enrollment	51 (Actual)
Sponsor	Kırıkkale University (Other)
Conditions	Pulpitis, Pulp Inflammation, Healthy Pulp, Biomarkers, Reversible Pulpitis
Dates	start 2025-03-03, primary completion 2025-09-03, completion 2025-10-03, first posted 2025-04-20, last updated 2025-12-05
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Healthy pulp group
Irreversible pulpitis group
Reversible pulpitis group

+Outcome measures

Primary outcomes

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

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

+Eligibility

Sex: All, ages: 16 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Kırıkkale University Faculty of Dentistry	Kirikkale	Turkey (Türkiye)