Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Bengüsu ÖNAL
- Número de teléfono: 05313806524
- Correo electrónico: bengusukirpi@gmail.com
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association Between Initial Pulpal Blood pH (pH₁) and 12-Month Vital Pulp Therapy Outcome
Periodo de tiempo: 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. |
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
Periodo de tiempo: 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. |
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
Periodo de tiempo: 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. |
From baseline (treatment day) to the 12-month follow-up for each participant.
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinically Relevant Threshold Value of Initial Pulpal Blood pH (pH₁) for 12-Month VPT Outcome
Periodo de tiempo: From baseline (treatment day) to the 12-month follow-up for each participant.
|
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). |
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
Periodo de tiempo: From baseline (treatment day) to the 12-month follow-up for each participant.
|
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). |
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
Periodo de tiempo: From baseline (treatment day) to the 12-month follow-up for each participant.
|
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). |
From baseline (treatment day) to the 12-month follow-up for each participant.
|
|
Correlation Between Pulpal and Systemic Oxygen Saturation (SpO₂)
Periodo de tiempo: Measurements obtained on the treatment day (baseline).
|
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 (%). |
Measurements obtained on the treatment day (baseline).
|
|
Correlation Between Initial Pulpal Blood pH (pH₁) and Venous Blood pH
Periodo de tiempo: Measurements obtained on the treatment day (baseline).
|
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. |
Measurements obtained on the treatment day (baseline).
|
|
Correlation Between Post-Pulpotomy Pulpal Blood pH (pH₂) and Venous Blood pH
Periodo de tiempo: Measurements obtained on the treatment day (baseline).
|
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. |
Measurements obtained on the treatment day (baseline).
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Ertuğrul KARATAŞ, Ataturk University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- ATA-ENDO-VPTPH-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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