Reversible PulpitisPULPBIOMNCT07658742
Biomarkers for Differentiating Reversible and Irreversible Pulpitis
An observational study of Reversible Pulpitis and Irreversible Pulpitis, run by Safa at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis, Irreversible Pulpitis, Healthy Pulp
- What is being tested?
- Pulpal Blood Biomarker Analysis
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 10 Jun 2026
- 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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adults aged 12-35 years who presented to the Department of Endodontics or Pediatric Dentistry for routine restorative or root canal treatment and met the study eligibility criteria. Participants were classified into three groups according to pulpal diagnosis: normal pulp, reversible pulpitis, and irreversible pulpitis. Only systemically healthy individuals with vital teeth and sufficient pulpal blood sample collection during routine treatment procedures were included.
Who may be able to join
- Individuals aged 12 to 35 years
- Systemically healthy individuals
- Patients presenting for routine restorative treatment or root canal treatment
- Teeth classified into one of the following pulpal status groups: healthy pulp, reversible pulpitis, or irreversible pulpitis
- Confirmation of pulp vitality by pulp sensibility tests
- Ability to obtain pulp exposure and collect an adequate pulpal blood sample during treatment
Who cannot join
- No response to pulp sensibility tests
- Teeth that are not restorable
- Presence of a sinus tract
- Radiographic evidence of periapical pathology
- Presence of internal or external root resorption
- Teeth with open apices
Show all 11Show fewer
- Presence of systemic disease
- Pregnancy
- History of non-steroidal anti-inflammatory drug (NSAID) or antibiotic use within the last week
- Requirement for prophylactic antibiotic use
- Teeth in which pulp exposure cannot be achieved after complete caries removal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, Kütahya, 43100
About this study
Official title: Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis
This observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis.
A total of 75 teeth from systemically healthy individuals aged 12-35 years will be included and classified into three groups: normal pulp, reversible pulpitis, and irreversible pulpitis, based on clinical examination, radiographic findings, and pulp sensibility tests. No additional treatment procedures will be performed for research purposes. All dental procedures will be carried out according to routine clinical protocols.
During routine treatment, after pulp exposure, approximately 50 μL of pulpal blood that would otherwise be discarded as medical waste will be collected using a micropipette. Samples will be stored and analyzed using Enzyme-Linked ImmunoSorbent Assay (ELISA) to determine the levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers. The results will be compared among the three groups to identify biomarkers that may improve the accuracy of pulpitis diagnosis and support clinical decision-making.
Read the detailed description
Current diagnosis of pulpal status relies primarily on clinical symptoms, sensibility tests, and radiographic findings, which may not always accurately reflect the underlying histopathological condition of the pulp. This study aims to investigate inflammatory, neurogenic, immunological, and oxidative stress biomarkers obtained from pulpal blood samples collected during routine dental treatment. Biomarker levels will be compared among teeth with normal pulp, reversible pulpitis, and irreversible pulpitis. The findings may contribute to the development of objective diagnostic tools for more accurate differentiation of pulpal conditions and improved treatment decision-making.
- Conditions
- Reversible Pulpitis, Irreversible Pulpitis, Healthy Pulp
- Being tested
- Pulpal Blood Biomarker Analysis
- Keywords
- Pulpitis, Irreversible Pulpitis, Pulp Blood, Biomarkers, Dental Pulp, ELISA
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpal Blood Biomarker AnalysisDiagnostic test
Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
| Study group | Role | What they receive |
|---|---|---|
| Normal Pulp | Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications. Receives: Diagnostic Test: Pulpal Blood Biomarker Analysis | |
| Reversible Pulpitis | Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests. Receives: Diagnostic Test: Pulpal Blood Biomarker Analysis | |
| Irreversible Pulpitis | Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests. Receives: Diagnostic Test: Pulpal Blood Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
Comparison of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), matrix metalloproteinase-9 (MMP-9), transforming growth factor-beta 1 (TGF-β1), presepsin, substance p, semaphoric 3A (SEMA3A), semaphoric 4D (SEMA4D), semaphoric 7A (SEMA7A), total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD) levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.
Measured: At the time of treatment (baseline)
Secondary outcomes (1)
Diagnostic performance of pulpal blood biomarkers
Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.
Measured: At the time of treatment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Nov 2025
- Primary completion1 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Safa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safa, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658742
- Sponsor's protocol ID
- KURNAZ-PULPBIOMARKERS
- Acronym
- PULPBIOM
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07658742
- Acronym / sponsor ID
- PULPBIOM / KURNAZ-PULPBIOMARKERS
- Conditions
- Reversible Pulpitis, Irreversible Pulpitis, Healthy Pulp
- Keywords
- Pulpitis, Irreversible Pulpitis, Pulp Blood, Biomarkers, Dental Pulp, ELISA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SafaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 22 Jun 2026 (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 observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis.
A total of 75 teeth from systemically healthy individuals aged 12-35 years will be included and classified into three groups: normal pulp, reversible pulpitis, and irreversible pulpitis, based on clinical examination, radiographic findings, and pulp sensibility tests. No additional treatment procedures will be performed for research purposes. All dental procedures will be carried out according to routine clinical protocols.
During routine treatment, after pulp exposure, approximately 50 μL of pulpal blood that would otherwise be discarded as medical waste will be collected using a micropipette. Samples will be stored and analyzed using Enzyme-Linked ImmunoSorbent Assay (ELISA) to determine the levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers. The results will be compared among the three groups to identify biomarkers that may improve the accuracy of pulpitis diagnosis and support clinical decision-making.
Detailed description
Current diagnosis of pulpal status relies primarily on clinical symptoms, sensibility tests, and radiographic findings, which may not always accurately reflect the underlying histopathological condition of the pulp. This study aims to investigate inflammatory, neurogenic, immunological, and oxidative stress biomarkers obtained from pulpal blood samples collected during routine dental treatment. Biomarker levels will be compared among teeth with normal pulp, reversible pulpitis, and irreversible pulpitis. The findings may contribute to the development of objective diagnostic tools for more accurate differentiation of pulpal conditions and improved treatment decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Pulp | – | Diagnostic Test: Pulpal Blood Biomarker AnalysisTeeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications. |
| Reversible Pulpitis | – | Diagnostic Test: Pulpal Blood Biomarker AnalysisTeeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests. |
| Irreversible Pulpitis | – | Diagnostic Test: Pulpal Blood Biomarker AnalysisTeeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adults aged 12-35 years who presented to the Department of Endodontics or Pediatric Dentistry for routine restorative or root canal treatment and met the study eligibility criteria. Participants were classified into three groups according to pulpal diagnosis: normal pulp, reversible pulpitis, and irreversible pulpitis. Only systemically healthy individuals with vital teeth and sufficient pulpal blood sample collection during routine treatment procedures were included.
Key inclusion criteria (6 listed)
- Individuals aged 12 to 35 years
- Systemically healthy individuals
- Patients presenting for routine restorative treatment or root canal treatment
- Teeth classified into one of the following pulpal status groups: healthy pulp, reversible pulpitis, or irreversible pulpitis
- Confirmation of pulp vitality by pulp sensibility tests
Key exclusion criteria (11 listed)
- No response to pulp sensibility tests
- Teeth that are not restorable
- Presence of a sinus tract
- Radiographic evidence of periapical pathology
- Presence of internal or external root resorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulpal Blood Biomarker AnalysisCollection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA. | Diagnostic test | Irreversible Pulpitis, Normal Pulp, Reversible Pulpitis |
Primary outcome
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
Time frame: At the time of treatment (baseline)
Comparison of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), matrix metalloproteinase-9 (MMP-9), transforming growth factor-beta 1 (TGF-β1), presepsin, substance p, semaphoric 3A (SEMA3A), semaphoric 4D (SEMA4D), semaphoric 7A (SEMA7A), total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD) levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.
1 secondary outcome
Diagnostic performance of pulpal blood biomarkers
Time frame: At the time of treatment (baseline)
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 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Reversible Pulpitis
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Recruiting
Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
Pulpitis - Reversible, Pulpotomies on Primary Molars
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Recruiting
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
Reversible Pulpitis, Deep Caries
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 Reversible Pulpitis and Irreversible Pulpitis, run by Safa 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 6 inclusion and 11 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 31 Jul 2026. 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?
Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples (time frame: At the time of treatment (baseline)). 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 31 Jul 2026.