Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulpitis
Pulp Inflammation
Healthy Pulp
Biomarkers
Reversible Pulpitis
Keywords: pulpal diagnosis
VEGF
pulpitis
FGF-1
IL-8
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients aged between 14-60 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).

Brief summary: This study will include 50 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.


Eligibility criteria: 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

Primary outcomes:
measure: IL-8, FGF-1 and VEGF expression levels in dentinal fluid, GCF and pulp tissue samples
timeFrame: Day 1
Secondary outcomes:
measure: Correlation analysis between IL-8, FGF-1 and VEGF levels in dentinal fluid, GCF and pulp tissue samples
timeFrame: Day 1
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Faculty of Dentistry
Study officials:
References: