Clinical Trial

Diagnostic Validity of a Quantitative Pulp Pain Scoring System and Its Association With Postoperative Clinical Outcomes

Completed
View on ClinicalTrials.gov →
Summary
Pulpal diseases are among the most common reasons for endodontic treatment in dental practice. The dental pulp plays a critical role in maintaining tooth vitality, and its pathological changes directly affect pain perception and patient quality of life. Therefore, accurate diagnosis of pulpal diseases is essential for patient-centered treatment planning. Distinguishing between reversible and irreversible pulpitis remains a major diagnostic challenge in endodontics, as this distinction relies largely on subjective symptom characteristics that vary considerably among patients. This uncertainty particularly affects newly graduated dentists, highlighting the need for objective and reproducible diagnostic tools in both dental education and clinical practice. To address these challenges, several classification systems for pulpal disease assessment have been proposed. Recently, Kumar et al. introduced the Pulp Pain Assessment Tool, a validated 11-item scoring system that quantifies both the intensity and qualitative aspects of pulpal pain. This tool generates scores ranging from 11 to 44, with a statistically determined cut-off value of 25 to differentiate reversible from irreversible pulpitis, providing a reproducible and standardized diagnostic framework. Although this quantitative approach may improve diagnostic objectivity and clinical decision-making, its agreement with established systems such as the American Association of Endodontists (AAE) classification and the Wolters diagnostic framework has not yet been systematically evaluated. Therefore, the primary aim of this study was to assess the diagnostic validity of Kumar's pulp pain assessment tool and its concordance with the AAE and Wolters classification systems. The secondary aim was to evaluate the relationship between total symptom scores and postoperative outcomes, including pain levels and analgesic consumption, according to the type of treatment performed (vital pulp therapy or root canal treatment). The null hypotheses were that there would be no significant difference in diagnostic agreement among the AAE classification, the Wolters system, and Kumar's scoring model, and that total symptom scores would not be associated with postoperative pain or analgesic consumption.
Trial Details
NCT Number NCT07349511
Lead Sponsor Recep Tayyip Erdogan University
Conditions Postoperative Pain After Endodontic Treatment, Direct Pulp Capping, Vital Pulp Therapy
Enrollment 143 participants
Start Date 2025-11-04
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-16