PulpitisNCT06936553
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 of Pulpitis and Pulp Inflammation, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Pulp Inflammation, Healthy Pulp
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 3 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Faculty of Dentistry
Kirikkale, 71450
About this study
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.
- Conditions
- Pulpitis, Pulp Inflammation, Healthy Pulp, Biomarkers, Reversible Pulpitis
- Keywords
- pulpal diagnosis, VEGF, pulpitis, FGF-1, IL-8
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy pulp group | Not described | |
| Irreversible pulpitis group | Not described | |
| Reversible pulpitis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start3 Mar 2025
- Primary completion3 Sep 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Erdemir, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936553
- Sponsor's protocol ID
- 2024/149
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06936553
- Acronym / sponsor ID
- 2024/149
- Conditions
- Pulpitis, Pulp Inflammation, Healthy Pulp, Biomarkers, Reversible Pulpitis
- Keywords
- pulpal diagnosis, VEGF, pulpitis, FGF-1, IL-8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy pulp group | – | – |
| Irreversible pulpitis group | – | – |
| Reversible pulpitis group | – | – |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (14 listed)
- 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
- Teeth that react mildly to cold, hot, sour or sweet stimuli
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation analysis between IL-8, FGF-1 and VEGF levels in dentinal fluid, GCF and pulp tissue samples
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulpitis and Pulp Inflammation, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-8, FGF-1 and VEGF expression levels in dentinal fluid, GCF and pulp tissue samples (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.