Vital Pulp TherapiesNCT07848698
Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
An observational study of Vital Pulp Therapies and pH, run by ertuğrul karataş.
Trial summary
The increasing emphasis on biological tissue preservation in contemporary endodontics has positioned vital pulp therapy (VPT) as an important treatment strategy for maintaining pulp vitality and preserving the functional integrity of the pulp-dentine complex. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapies, pH, pH Changes
- What is being tested?
- vital pulp therapy
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Aug 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients aged 16-50 years presenting with permanent molar teeth affected by deep dentinal caries will be consecutively screened for eligibility, with a total of 96 eligible participants recruited into the study. Teeth diagnosed with reversible pulpitis or symptomatic irreversible pulpitis, exhibiting positive responses to both cold testing and electric pulp testing (EPT) and no radiographic evidence of apical radiolucency will be eligible for inclusion in the study. Prior to enrolment, all participants will receive detailed verbal and written information regarding the study protocol. Written informed consent will be obtained before any clinical procedures are performed. Baseline demographic and clinical information, including age, sex, tooth type, pulpal diagnosis, presenting symptoms, clinical findings and radiographic characteristics will be recorded using standardized case report forms.
Who may be able to join
- Patients aged 16-50 years who provide written informed consent to participate in the study.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I.
- Permanent molar teeth with deep dentinal caries considered suitable for vital pulp therapy.
- Teeth diagnosed with reversible pulpitis or symptomatic irreversible pulpitis based on predefined clinical diagnostic criteria.
- Teeth exhibiting a positive response to both cold testing and electric pulp testing (EPT).
- Teeth without tenderness to percussion or palpation.
Show all 9Show fewer
- Teeth without clinical evidence of swelling or sinus tract.
- Teeth without radiographic evidence of apical radiolucency.
- Teeth considered restorable and suitable for adequate rubber-dam isolation.
Who cannot join
- Teeth exhibiting a negative response to cold testing and/or EPT or diagnosed with pulp necrosis.
- Teeth with radiographic evidence of apical radiolucency.
- Teeth with a history of previous root canal treatment.
- Teeth with internal or external root resorption, vertical or horizontal root fracture or a history of dental trauma.
- Teeth with pathological mobility or generalized periodontitis.
- Teeth with swelling or a sinus tract.
Show all 12Show fewer
- Teeth that cannot be adequately isolated using a rubber dam.
- Teeth with extensive pre-existing coronal restorations, full-coverage crowns or other conditions that may interfere with appropriate positioning of the pulse oximeter probe or optical signal transmission.
- Patients classified as ASA II or higher.
- Patients who have used antibiotics, bisphosphonates, or statins within the four weeks preceding treatment.
- Patients who have taken analgesic medication within 48 hours before treatment.
- Pregnant patients or those with suspected pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Interventional Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
The increasing emphasis on biological tissue preservation in contemporary endodontics has positioned vital pulp therapy (VPT) as an important treatment strategy for maintaining pulp vitality and preserving the functional integrity of the pulp-dentine complex. Advances in biomaterials and understanding of pulpal healing have expanded the indications for VPT and contributed to favourable clinical outcomes; however, appropriate case selection remains a critical determinant of treatment success. Currently, the clinical assessment of pulpal status before VPT relies on a combination of patient-reported symptoms, clinical and radiographic findings, pulp sensibility testing and intraoperative assessment of pulpal bleeding. Although clinically valuable, these parameters do not provide a direct and objective measure of the biological status or healing potential of the pulp and may be influenced by clinical interpretation. Consequently, there remains a need for objective biological parameters that provide more direct information on pulpal status and healing potential, thereby supporting case selection and prognostic assessment in VPT.
Progressive pulpal inflammation is accompanied by increased production of inflammatory mediators, vascular congestion, enhanced vascular permeability, impaired microcirculation, and reduced tissue perfusion. These vascular alterations may compromise oxygen delivery to the pulp, resulting in reduced pulpal oxygen saturation (SpO2). As oxygen availability decreases, cellular metabolism shifts towards anaerobic pathways, promoting the accumulation of acidic metabolites, which may consequently lead to a reduction in pulpal blood pH. Accordingly, pulpal SpO2 and pulpal blood pH may represent complementary physiological and metabolic indicators of pulpal inflammatory status. Their assessment may provide objective information on the biological condition and healing potential of the pulp that is not directly captured by conventional diagnostic methods. Consistent with these observations, Hosseinzadehfard et al. (2026) reported that pulpal blood pH and SpO2 varied with pulpal diagnostic status, supporting their potential value as objective indicators of pulpal inflammation. However, their study focused on the diagnostic relevance of these parameters rather than their association with VPT success. To date, their association with subsequent treatment outcomes and clinically relevant thresholds for outcome prediction remain to be established.
The present prospective clinical study aims to investigate the association of pulpal blood pH and pulpal SpO2, individually and in combination, with the clinical and radiographic outcome of VPT at the 12-month follow-up, and to determine clinically relevant threshold values associated with treatment success. Pulpal blood pH will be assessed both immediately after initial pulp exposure and following pulpotomy in the remaining vital pulp tissue, allowing evaluation of the relationship between the two pH measurements. Systemic oxygen saturation and venous blood pH will additionally serve as physiological reference measures. The findings may provide an evidence-based foundation for a more objective and biologically informed approach to case selection and prognostic assessment in VPT.
- Conditions
- Vital Pulp Therapies, pH, pH Changes, Oxygen Saturation
- Being tested
- vital pulp therapy
- Keywords
- vital pulp therapy, pH, oxygen saturation, pulp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vital pulp therapyProcedure or surgery
Vital pulp therapy will be performed according to each patient's clinical indication. Following pulp exposure, pulpal blood pH will be measured before the application of any hemostatic agent. A second pH measurement will be obtained from the remaining vital pulp tissue after pulpotomy, where applicable. Biodentine will be used as the calcium silicate-based treatment material. Clinical and radiographic outcomes will be assessed over a 12-month follow-up period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Initial Pulpal Blood pH (pH₁) and 12-Month Vital Pulp Therapy Outcome
Initial pulpal blood pH (pH₁) will be measured immediately after pulp exposure and before the application of any hemostatic agent, irrigation solution, or pulp-capping material. Approximately 50 µL of freely available pulpal blood will be collected using a sterile single-use microcapillary tube and immediately measured using a HORIBA LAQUAtwin pH-33 microvolume pH meter with Sampling Sheet B. Values will be reported in pH units. The association between pH₁ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Association Between Post-Pulpotomy Pulpal Blood pH (pH₂) and 12-Month Vital Pulp Therapy Outcome
Among participants undergoing pulpotomy, post-pulpotomy pulpal blood pH (pH₂) will be measured from the remaining vital pulp tissue before the application of any hemostatic agent, disinfectant solution or pulp-capping material. Approximately 50 µL of freely available pulpal blood will be collected using a sterile single-use microcapillary tube and immediately measured using a HORIBA LAQUAtwin pH-33 microvolume pH meter with Sampling Sheet B. Values will be reported in pH units. The association between pH₂ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Association Between Pulpal Oxygen Saturation (SpO₂) and 12-Month Vital Pulp Therapy Outcome
Pulpal oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%). The association between pulpal SpO₂ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Secondary outcomes (6)
Clinically Relevant Threshold Value of Initial Pulpal Blood pH (pH₁) for 12-Month VPT Outcome
A clinically relevant threshold value for initial pulpal blood pH (pH₁) in relation to the 12-month clinical and radiographic outcome of vital pulp therapy will be determined using receiver operating characteristic (ROC) curve analysis. pH₁ will be reported in pH units. The prognostic performance of the identified threshold will be evaluated using the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Clinically Relevant Threshold Value of Post-Pulpotomy Pulpal Blood pH (pH₂) for 12-Month VPT Outcome
Among participants undergoing pulpotomy, a clinically relevant threshold value for post-pulpotomy pulpal blood pH (pH₂) in relation to the 12-month clinical and radiographic outcome of vital pulp therapy will be determined using receiver operating characteristic (ROC) curve analysis. pH₂ will be reported in pH units. The prognostic performance of the identified threshold will be evaluated using the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Clinically Relevant Threshold Value of Pulpal Oxygen Saturation (SpO₂) for 12-Month VPT Outcome
A clinically relevant threshold value for pulpal oxygen saturation (SpO₂) in relation to the 12-month clinical and radiographic outcome of vital pulp therapy will be determined using receiver operating characteristic (ROC) curve analysis. Pulpal SpO₂ will be reported as a percentage (%). The prognostic performance of the identified threshold will be evaluated using the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: From baseline (treatment day) to the 12-month follow-up for each participant.
Correlation Between Pulpal and Systemic Oxygen Saturation (SpO₂)
The correlation between pulpal oxygen saturation (SpO₂) and systemic oxygen saturation (SpO₂) measured at the index finger will be evaluated. Systemic SpO₂ will serve as the physiological reference measure for pulpal oxygen saturation. Both measurements will be obtained using pulse oximetry and reported as a percentage (%).
Measured: Measurements obtained on the treatment day (baseline).
Correlation Between Initial Pulpal Blood pH (pH₁) and Venous Blood pH
Initial pulpal blood pH (pH₁) will be measured using a HORIBA LAQUAtwin pH-33 microvolume pH meter and reported in pH units. Venous blood pH will be measured using venous blood gas analysis and reported in pH units. The correlation between pH₁ and venous blood pH will be evaluated, with venous blood pH serving as the systemic physiological reference measure.
Measured: Measurements obtained on the treatment day (baseline).
Correlation Between Post-Pulpotomy Pulpal Blood pH (pH₂) and Venous Blood pH
Among participants undergoing pulpotomy, post-pulpotomy pulpal blood pH (pH₂) will be measured from the remaining vital pulp tissue using a HORIBA LAQUAtwin pH-33 microvolume pH meter and reported in pH units. Venous blood pH will be measured using venous blood gas analysis and reported in pH units. The correlation between pH₂ and venous blood pH will be evaluated, with venous blood pH serving as the systemic physiological reference measure.
Measured: Measurements obtained on the treatment day (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vital Pulp TherapiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- ertuğrul karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ertuğrul karataş, Ataturk University
- Investigators
- Ertuğrul KARATAŞ, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848698
- Sponsor's protocol ID
- ATA-ENDO-VPTPH-2026-01
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hosseinzadehfard P, Skucaite N, Maciulskiene-Visockiene V, Lodiene G. Blood pH Changes in Dental Pulp of Patients with Pulpitis. Diagnostics (Basel). 2024 May 29;14(11):1128. doi: 10.3390/diagnostics14111128.
PubMed 38893654Grabliauskiene Z, Zamaliauskiene R, Lodiene G. Pulp Vitality Testing with a Developed Universal Pulse Oximeter Probe Holder. Medicina (Kaunas). 2021 Jan 23;57(2):101. doi: 10.3390/medicina57020101.
PubMed 33498652Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17.
PubMed 37392154Jiang M, Liu H. Biological markers and pulp pH values for the clinical prediction of suppurative pulpitis. Am J Transl Res. 2026 Jan 15;18(1):512-523. doi: 10.62347/HFPB3000. eCollection 2026.
PubMed 41676246
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07848698
- Acronym / sponsor ID
- ATA-ENDO-VPTPH-2026-01
- Conditions
- Vital Pulp Therapies, pH, pH Changes, Oxygen Saturation
- Keywords
- vital pulp therapy, pH, oxygen saturation, pulp
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- ertuğrul karataşUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 30 Sep 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.
The increasing emphasis on biological tissue preservation in contemporary endodontics has positioned vital pulp therapy (VPT) as an important treatment strategy for maintaining pulp vitality and preserving the functional integrity of the pulp-dentine complex. Advances in biomaterials and understanding of pulpal healing have expanded the indications for VPT and contributed to favourable clinical outcomes; however, appropriate case selection remains a critical determinant of treatment success. Currently, the clinical assessment of pulpal status before VPT relies on a combination of patient-reported symptoms, clinical and radiographic findings, pulp sensibility testing and intraoperative assessment of pulpal bleeding. Although clinically valuable, these parameters do not provide a direct and objective measure of the biological status or healing potential of the pulp and may be influenced by clinical interpretation. Consequently, there remains a need for objective biological parameters that provide more direct information on pulpal status and healing potential, thereby supporting case selection and prognostic assessment in VPT.
Progressive pulpal inflammation is accompanied by increased production of inflammatory mediators, vascular congestion, enhanced vascular permeability, impaired microcirculation, and reduced tissue perfusion. These vascular alterations may compromise oxygen delivery to the pulp, resulting in reduced pulpal oxygen saturation (SpO2). As oxygen availability decreases, cellular metabolism shifts towards anaerobic pathways, promoting the accumulation of acidic metabolites, which may consequently lead to a reduction in pulpal blood pH. Accordingly, pulpal SpO2 and pulpal blood pH may represent complementary physiological and metabolic indicators of pulpal inflammatory status. Their assessment may provide objective information on the biological condition and healing potential of the pulp that is not directly captured by conventional diagnostic methods. Consistent with these observations, Hosseinzadehfard et al. (2026) reported that pulpal blood pH and SpO2 varied with pulpal diagnostic status, supporting their potential value as objective indicators of pulpal inflammation. However, their study focused on the diagnostic relevance of these parameters rather than their association with VPT success. To date, their association with subsequent treatment outcomes and clinically relevant thresholds for outcome prediction remain to be established.
The present prospective clinical study aims to investigate the association of pulpal blood pH and pulpal SpO2, individually and in combination, with the clinical and radiographic outcome of VPT at the 12-month follow-up, and to determine clinically relevant threshold values associated with treatment success. Pulpal blood pH will be assessed both immediately after initial pulp exposure and following pulpotomy in the remaining vital pulp tissue, allowing evaluation of the relationship between the two pH measurements. Systemic oxygen saturation and venous blood pH will additionally serve as physiological reference measures. The findings may provide an evidence-based foundation for a more objective and biologically informed approach to case selection and prognostic assessment in VPT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 16-50 years presenting with permanent molar teeth affected by deep dentinal caries will be consecutively screened for eligibility, with a total of 96 eligible participants recruited into the study. Teeth diagnosed with reversible pulpitis or symptomatic irreversible pulpitis, exhibiting positive responses to both cold testing and electric pulp testing (EPT) and no radiographic evidence of apical radiolucency will be eligible for inclusion in the study. Prior to enrolment, all participants will receive detailed verbal and written information regarding the study protocol. Written informed consent will be obtained before any clinical procedures are performed. Baseline demographic and clinical information, including age, sex, tooth type, pulpal diagnosis, presenting symptoms, clinical findings and radiographic characteristics will be recorded using standardized case report forms.
Key inclusion criteria (9 listed)
- Patients aged 16-50 years who provide written informed consent to participate in the study.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I.
- Permanent molar teeth with deep dentinal caries considered suitable for vital pulp therapy.
- Teeth diagnosed with reversible pulpitis or symptomatic irreversible pulpitis based on predefined clinical diagnostic criteria.
- Teeth exhibiting a positive response to both cold testing and electric pulp testing (EPT).
Key exclusion criteria (12 listed)
- Teeth exhibiting a negative response to cold testing and/or EPT or diagnosed with pulp necrosis.
- Teeth with radiographic evidence of apical radiolucency.
- Teeth with a history of previous root canal treatment.
- Teeth with internal or external root resorption, vertical or horizontal root fracture or a history of dental trauma.
- Teeth with pathological mobility or generalized periodontitis.
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 therapyVital pulp therapy will be performed according to each patient's clinical indication. Following pulp exposure, pulpal blood pH will be measured before the application of any hemostatic agent. A second pH measurement will be obtained from the remaining vital pulp tissue after pulpotomy, where applicable. Biodentine will be used as the calcium silicate-based treatment material. Clinical and radiographic outcomes will be assessed over a 12-month follow-up period. | Procedure or surgery | – |
Primary outcome
Association Between Initial Pulpal Blood pH (pH₁) and 12-Month Vital Pulp Therapy Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Initial pulpal blood pH (pH₁) will be measured immediately after pulp exposure and before the application of any hemostatic agent, irrigation solution, or pulp-capping material. Approximately 50 µL of freely available pulpal blood will be collected using a sterile single-use microcapillary tube and immediately measured using a HORIBA LAQUAtwin pH-33 microvolume pH meter with Sampling Sheet B. Values will be reported in pH units. The association between pH₁ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
Association Between Post-Pulpotomy Pulpal Blood pH (pH₂) and 12-Month Vital Pulp Therapy Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Among participants undergoing pulpotomy, post-pulpotomy pulpal blood pH (pH₂) will be measured from the remaining vital pulp tissue before the application of any hemostatic agent, disinfectant solution or pulp-capping material. Approximately 50 µL of freely available pulpal blood will be collected using a sterile single-use microcapillary tube and immediately measured using a HORIBA LAQUAtwin pH-33 microvolume pH meter with Sampling Sheet B. Values will be reported in pH units. The association between pH₂ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
Association Between Pulpal Oxygen Saturation (SpO₂) and 12-Month Vital Pulp Therapy Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Pulpal oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%). The association between pulpal SpO₂ and the 12-month clinical and radiographic outcome of vital pulp therapy (success or failure) will be evaluated.
6 secondary outcomes
Clinically Relevant Threshold Value of Initial Pulpal Blood pH (pH₁) for 12-Month VPT Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Clinically Relevant Threshold Value of Post-Pulpotomy Pulpal Blood pH (pH₂) for 12-Month VPT Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Clinically Relevant Threshold Value of Pulpal Oxygen Saturation (SpO₂) for 12-Month VPT Outcome
Time frame: From baseline (treatment day) to the 12-month follow-up for each participant.
Correlation Between Pulpal and Systemic Oxygen Saturation (SpO₂)
Time frame: Measurements obtained on the treatment day (baseline).
Correlation Between Initial Pulpal Blood pH (pH₁) and Venous Blood pH
Time frame: Measurements obtained on the treatment day (baseline).
Correlation Between Post-Pulpotomy Pulpal Blood pH (pH₂) and Venous Blood pH
Time frame: Measurements obtained on the treatment day (baseline).
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 30 Sep 2026.
- Results publication: PubMed 38893654Hosseinzadehfard P, Skucaite N, Maciulskiene-Visockiene V, Lodiene G. Blood pH Changes in Dental Pulp of Patients with Pulpitis. Diagnostics (Basel). 2024 May 29;14(11):1128. doi: 10.3390/diagnostics14111128.
- Results publication: PubMed 33498652Grabliauskiene Z, Zamaliauskiene R, Lodiene G. Pulp Vitality Testing with a Developed Universal Pulse Oximeter Probe Holder. Medicina (Kaunas). 2021 Jan 23;57(2):101. doi: 10.3390/medicina57020101.
- Results publication: PubMed 37392154Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17.
- Results publication: PubMed 41676246Jiang M, Liu H. Biological markers and pulp pH values for the clinical prediction of suppurative pulpitis. Am J Transl Res. 2026 Jan 15;18(1):512-523. doi: 10.62347/HFPB3000. eCollection 2026.
- Individual participant dataSharing planned: Yes
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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.
Ertuğrul KARATAŞ study director
Ataturk University
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Pulp Therapies and pH, run by ertuğrul karataş.
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 12 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Bengüsu ÖNAL (05313806524, bengusukirpi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Initial Pulpal Blood pH (pH₁) and 12-Month Vital Pulp Therapy Outcome (time frame: From baseline (treatment day) to the 12-month follow-up for each participant.). The study lists 3 primary outcomes in all. 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 NCT07848698, which also lists 4 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 30 Sep 2026.