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NCT07848698

Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study

Sponsor: ertuğrul karataş

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

16 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

96

Start Date

2026-10-01

Completion Date

2028-08-01

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

PROCEDURE

vital pulp therapy

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.