Reversible PulpitisNCT07073573
Evaluation of Pulpal Biomarkers in Vital Pulp Therapy
A study testing Vital pulp therapy in people with Reversible Pulpitis and Irreversible Pulpitis, run by ertuğrul karataş at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to evaluate the association between the levels of selected pulpal biomarkers and the clinical success of vital pulp therapy in permanent teeth. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Reversible Pulpitis, Irreversible Pulpitis, Vital Pulp Therapy
- What is being tested?
- Vital pulp therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 3 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Permanent teeth diagnosed with reversible pulpitis
- Patients diagnosed with irreversible pulpitis but without apical radiolucency
- Teeth showing a normal response to cold testing (carbon dioxide snow)
- Teeth with irreversible pulpitis demonstrating prolonged response to cold testing
- Teeth with no sensitivity to percussion or chewing
- In teeth with exposed pulp tissue, bleeding time less than 5 minutes
Show all 9Show fewer
- In irreversible pulpitis cases, bleeding time less than 10 minutes
- No widening of the periodontal ligament space (periapical index [PAI] ≤ 2)
- Radiographic evidence of deep dentinal caries
Who cannot join
- Teeth with a negative response to cold testing (carbon dioxide snow)
- Presence of apical radiolucency (PAI > 2)
- Condensed apical periodontitis
- Internal or external root resorption
- History of dental trauma
- Longitudinal root fracture
Show all 14Show fewer
- Presence of periodontal-endodontic lesions on the day of treatment
- Functional loss (e.g., Grade 3 tooth mobility)
- Swelling associated with the treated tooth
- Teeth that cannot be treated under rubber dam isolation
- Teeth from which less than 2.5 mL of pulpal blood can be collected
- Immunocompromised individuals
- Pregnant women at the time of treatment
- Use of antibiotics, bisphosphonates, or statins within 4 weeks prior to treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University, Faculty of Dentistry, Department of Endodontics
Erzurum, Erzurum, 25070
About this study
Official title: The Relationship Between Pulpal Biomarker Levels and the Success of Vital Pulp Therapy: A Prospective Clinical Study
This prospective clinical study aims to evaluate the association between the levels of selected pulpal biomarkers and the clinical success of vital pulp therapy in permanent teeth. Patients undergoing vital pulp therapy will be monitored over time, and biomarker expression levels will be analyzed in relation to treatment outcomes. The study intends to provide insight into the predictive value of pulp tissue biomarkers for long-term success in vital pulp procedures.
Read the detailed description
The aim of this study is to identify the biomarkers that influence the success of vital pulp therapy (VPT), a treatment that offers several advantages over conventional root canal therapy. The study also aims to evaluate the success of VPT in teeth diagnosed with irreversible pulpitis. The success of VPT largely depends on the accurate assessment of pulpal status.
This prospective clinical study will be conducted on 50 patients who apply to the Department of Endodontics, Faculty of Dentistry, Atatürk University, and meet the inclusion criteria. Informed consent will be obtained from all participants. A specially designed clinical assessment form will be completed for each patient to record clinical findings prior to the procedure.
Local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Following anesthesia, the teeth will be isolated using a rubber dam. Caries removal will be performed under an operating microscope (OPMI) using a diamond bur and aerator. All infected dentin will be removed selectively until hard dentin is reached.
Pulpal bleeding will be controlled by applying a cotton pellet moistened with sterile saline into the cavity for one minute. Subsequently, pulpal fluid and blood samples will be collected using 5 mm-long sterile paper points to ensure equal sample volume per case. Each sample (one per patient) will be transferred into separate sterile Eppendorf tubes containing 500 µL of phosphate-buffered saline (PBS) and stored at -80°C until biochemical analysis. Total bleeding time will be recorded using a chronometer.
The first tube will be used for the analysis of mediators including RANTES (CCL5), MCP-1, TNF-α, TGF-β, IL-1β, TIMP-1, MMP-12, and MMP-1. The second tube will be used to measure MDA, SDA, TAS, and TOS levels.
After sample collection, the exposed pulp will be disinfected with a cotton pellet soaked in 2.5% sodium hypochlorite for 30 seconds. The cavity will then be rinsed with sterile saline and dried. The exposed pulp will be capped with Mineral Trioxide Aggregate (MTA) according to the manufacturer's instructions, and permanent restoration of the tooth will be completed.
Patients will be recalled for follow-up evaluations at 3, 6, and 12 months, during which pulpal vitality will be assessed. A correlation will be established between biomarker levels and clinical success of the vital pulp therapy.
- Being tested
- Vital pulp therapy
- Keywords
- Pulpal Biomarkers, Vital Pulp Therapy, Inflammatory Cytokines, Dental Pulp Inflammation, Clinical Success, Biomarker Expression
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital pulp therapyProcedure or surgery
Also called Partial pulpotomy, Pulpotomy
Vital pulp therapy was performed using a calcium silicate-based material after caries removal and coronal pulp exposure. Hemostasis was achieved using sodium hypochlorite before placing the material. Permanent restoration was completed in the same session. Pulpal fluid samples were collected before the intervention to assess biomarker levels. The relationship between biomarker expression and the clinical success or longevity of the treated teeth was evaluated over time
| Study group | Role | What they receive |
|---|---|---|
| reversible pulpitis | Active comparator | Patients diagnosed with reversible pulpitis and treated accordingly Receives: Procedure: Vital pulp therapy |
| Irreversible Pulpitis | Active comparator | Patients diagnosed with irreversible pulpitis and treated accordingly Receives: Procedure: Vital pulp therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of treated teeth with Vital Pulp Therapy
Clinical and radiographic success will be defined as the absence of symptoms (e.g., spontaneous pain, swelling), no sinus tract, no pathological mobility, and no periapical radiolucency. In addition, a positive response to pulp vitality tests (e.g., cold test or EPT) will be considered as an indicator of maintained pulpal vitality.
Measured: 6-12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start3 Mar 2025
- Primary completion25 Jul 2025 (estimated)
- Study completion3 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel arms based on clinical diagnosis: reversible pulpitis or irreversible pulpitis
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ertuğrul karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ertuğrul karataş, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073573
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/535
- Other IDs
- NO-FUNDING-TRIAL-2025
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016.
PubMed 35887779Asgary S, Nosrat A. Vital Pulp Therapy: Evidence-Based Techniques and Outcomes. Iran Endod J. 2025;20(1):e2. doi: 10.22037/iej.v20i1.47141. Epub 2025 Jan 1.
PubMed 39935864
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pulpal Biomarker Levels and the Success of Vital Pulp Therapy: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07073573
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/535
- Keywords
- Pulpal Biomarkers, Vital Pulp Therapy, Inflammatory Cytokines, Dental Pulp Inflammation, Clinical Success, Biomarker Expression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ertuğrul karataşUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 3 Aug 2026 (estimated)
- First posted
- 18 Jul 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 prospective clinical study aims to evaluate the association between the levels of selected pulpal biomarkers and the clinical success of vital pulp therapy in permanent teeth. Patients undergoing vital pulp therapy will be monitored over time, and biomarker expression levels will be analyzed in relation to treatment outcomes. The study intends to provide insight into the predictive value of pulp tissue biomarkers for long-term success in vital pulp procedures.
Detailed description
The aim of this study is to identify the biomarkers that influence the success of vital pulp therapy (VPT), a treatment that offers several advantages over conventional root canal therapy. The study also aims to evaluate the success of VPT in teeth diagnosed with irreversible pulpitis. The success of VPT largely depends on the accurate assessment of pulpal status.
This prospective clinical study will be conducted on 50 patients who apply to the Department of Endodontics, Faculty of Dentistry, Atatürk University, and meet the inclusion criteria. Informed consent will be obtained from all participants. A specially designed clinical assessment form will be completed for each patient to record clinical findings prior to the procedure.
Local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Following anesthesia, the teeth will be isolated using a rubber dam. Caries removal will be performed under an operating microscope (OPMI) using a diamond bur and aerator. All infected dentin will be removed selectively until hard dentin is reached.
Pulpal bleeding will be controlled by applying a cotton pellet moistened with sterile saline into the cavity for one minute. Subsequently, pulpal fluid and blood samples will be collected using 5 mm-long sterile paper points to ensure equal sample volume per case. Each sample (one per patient) will be transferred into separate sterile Eppendorf tubes containing 500 µL of phosphate-buffered saline (PBS) and stored at -80°C until biochemical analysis. Total bleeding time will be recorded using a chronometer.
The first tube will be used for the analysis of mediators including RANTES (CCL5), MCP-1, TNF-α, TGF-β, IL-1β, TIMP-1, MMP-12, and MMP-1. The second tube will be used to measure MDA, SDA, TAS, and TOS levels.
After sample collection, the exposed pulp will be disinfected with a cotton pellet soaked in 2.5% sodium hypochlorite for 30 seconds. The cavity will then be rinsed with sterile saline and dried. The exposed pulp will be capped with Mineral Trioxide Aggregate (MTA) according to the manufacturer's instructions, and permanent restoration of the tooth will be completed.
Patients will be recalled for follow-up evaluations at 3, 6, and 12 months, during which pulpal vitality will be assessed. A correlation will be established between biomarker levels and clinical success of the vital pulp therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel arms based on clinical diagnosis: reversible pulpitis or irreversible pulpitis
| Arm | Type | Receives |
|---|---|---|
| reversible pulpitis | Active comparator | Procedure: Vital pulp therapyPatients diagnosed with reversible pulpitis and treated accordingly |
| Irreversible Pulpitis | Active comparator | Procedure: Vital pulp therapyPatients diagnosed with irreversible pulpitis and treated accordingly |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Permanent teeth diagnosed with reversible pulpitis
- Patients diagnosed with irreversible pulpitis but without apical radiolucency
- Teeth showing a normal response to cold testing (carbon dioxide snow)
- Teeth with irreversible pulpitis demonstrating prolonged response to cold testing
- Teeth with no sensitivity to percussion or chewing
Key exclusion criteria (14 listed)
- Teeth with a negative response to cold testing (carbon dioxide snow)
- Presence of apical radiolucency (PAI > 2)
- Condensed apical periodontitis
- Internal or external root resorption
- History of dental trauma
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 |
|---|---|---|
| Vital pulp therapyAlso: Partial pulpotomy, PulpotomyVital pulp therapy was performed using a calcium silicate-based material after caries removal and coronal pulp exposure. Hemostasis was achieved using sodium hypochlorite before placing the material. Permanent restoration was completed in the same session. Pulpal fluid samples were collected before the intervention to assess biomarker levels. The relationship between biomarker expression and the clinical success or longevity of the treated teeth was evaluated over time | Procedure or surgery | Irreversible Pulpitis, reversible pulpitis |
Primary outcome
Clinical success of treated teeth with Vital Pulp Therapy
Time frame: 6-12 months after treatment
Clinical and radiographic success will be defined as the absence of symptoms (e.g., spontaneous pain, swelling), no sinus tract, no pathological mobility, and no periapical radiolucency. In addition, a positive response to pulp vitality tests (e.g., cold test or EPT) will be considered as an indicator of maintained pulpal vitality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Results publication: PubMed 35887779Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016.
- Results publication: PubMed 39935864Asgary S, Nosrat A. Vital Pulp Therapy: Evidence-Based Techniques and Outcomes. Iran Endod J. 2025;20(1):e2. doi: 10.22037/iej.v20i1.47141. Epub 2025 Jan 1.
- Individual participant dataSharing planned: No
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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?
A study testing Vital pulp therapy in people with Reversible Pulpitis and Irreversible Pulpitis, run by ertuğrul karataş 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 9 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical success of treated teeth with Vital Pulp Therapy (time frame: 6-12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07073573, which also lists 2 linked publications.
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 20 Jul 2025.