Characterization of Pulp Inflammation: Observational Study Using Biological Samples
Summary
NIH registered ClinicalTrials.gov study NCT07533396, an observational investigation of pulpal inflammation using biological samples collected during routine dental care. The study aims to validate a new diagnostic classification (Endolight) for guiding vital pulp therapy indications and to identify molecular and protein biomarkers associated with inflammatory severity. The trial enrolls patients undergoing routine dental procedures and requires collection of biological samples for analysis.
What changed
ClinicalTrials.gov study NCT07533396 was registered by NIH documenting an observational study on pulpal inflammation characterization. The study will collect biological samples during routine dental procedures to assess inflammatory status and validate the Endolight diagnostic classification for vital pulp therapy indications. It seeks to identify molecular and protein biomarkers associated with inflammatory severity to improve treatment selection.
Affected parties include clinical investigators conducting dental research, healthcare providers collecting biological samples, and institutions performing vital pulp therapy procedures. Researchers and institutional review boards should note the study's parameters for informed consent and data sharing obligations. The registry entry provides no compliance deadlines or penalties.
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Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Characterization of Pulp Inflammation: an Observational Study Using Biological Samples Collected During Routine Dental Care
Observational NCT07533396 Kind: OBSERVATIONAL Apr 16, 2026
Abstract
Background: Vital pulp therapy (VPT) is a cornerstone of minimally invasive dentistry and aims to preserve pulp vitality whenever clinically feasible. Teeth with vital pulp show better long-term survival than endodontically treated teeth. However, the success of VPT procedures-such as indirect or direct pulp capping, partial pulpotomy, and full pulpotomy-critically depends on an accurate assessment of the extent and severity of pulpal inflammation. Current diagnostic classifications are mainly based on patient-reported symptoms and sensibility tests, which do not reliably reflect the underlying inflammatory status of the pulp tissue. This diagnostic uncertainty contributes to inappropriate treatment selection, early therapeutic failures, and wide variability in clinical practice.
Rationale: Pulpal inflammation is a dynamic and spatially heterogeneous biological process that progresses from localized to diffuse tissue involvement. Clinical studies have demonstrated discrepancies between clinical diagnosis and the actual histological and molecular status of the pulp. A new diagnostic classification (Endolight) has been proposed to better guide VPT indications by distinguishing different stages of pulpal inflammation, but it has not yet been validated against in situ biological analyses of human pulp tissue. Moreover, the identification of molecular and protein biomarkers associated with inflammatory severity could support the development of more accurate diagnostic and prog...
Conditions: Pulpal Inflammation
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