Comparison of IL-8, FGF-1 and VEGF Levels in Pulpal Tissue, GCF and Dentinal Fluid Samples of Hea… (NCT06936553) | Clinical Trial Compass
CompletedNot Applicable
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
Turkey (Türkiye)51 participantsStarted 2025-03-03
Plain-language 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.
Who can participate
Age range
16 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IL-8, FGF-1 and VEGF expression levels in dentinal fluid, GCF and pulp tissue samples