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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.
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  • 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.

Bengüsu ÖNAL contact

05313806524

bengusukirpi@gmail.com

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.

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.

  1. 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.

  2. 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.

  3. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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.

  1. First posted30 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

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
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 38893654
  • Grabliauskiene 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 33498652
  • Karrar 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 37392154
  • Jiang 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

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.

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