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

NCT07349511 | Completed

• 1 other identifier: MÇ
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain After Endodontic Treatment; Direct Pulp Capping; Vital Pulp Therapy

Keywords

pulpitis; postoperative pain; vital pulp therapy; pulp capping; root canal treatment

Outcome Measures

Primary Outcomes (1)

• Diagnostic concordance of the Pulp Pain Assessment Tool (PPAT) with established pulpal diagnostic systems

  Diagnostic agreement between the Pulp Pain Assessment Tool (PPAT) and the American Association of Endodontists (AAE) classification and the Wolters diagnostic system for pulpal disease, evaluated using Cohen's kappa coefficient.

  At baseline (at the time of patient presentation, prior to treatment)

Secondary Outcomes (1)

• Postoperative pain intensity

  Up to 7 days after treatment

Study Arms (2)

vital pulp therapy

EXPERIMENTAL

In this study, treatment planning was based on the total score obtained from the Youden symptom scoring system. Patients with scores below 25 were diagnosed with reversible pulpitis and treated with vital pulp therapy. Indirect pulp capping was performed in cases where no pulp exposure occurred during caries removal. Direct pulp capping was performed in cases where pulp exposure occurred during caries removal but the clinical and symptomatic findings were consistent with a diagnosis of reversible pulpitis.

Other: Vital pulp therapy procedure based on the total score obtained from the Youden symptom scoring system

root canal treatment

EXPERIMENTAL

Patients with scores of 25 or higher were diagnosed with irreversible pulpitis and treated with root canal therapy, to ensure standardized and reproducible treatment allocation.

Other: Root canal treatment procedure based on the total score obtained from the Youden symptom scoring system

Interventions

Vital pulp therapy procedure based on the total score obtained from the Youden symptom scoring system OTHER

All procedures were performed under rubber dam isolation, in a single visit, and by a single operator. Indirect pulp capping was performed in cases where no pulp exposure occurred during caries removal. In teeth with deep dentin caries but preserved pulpal integrity, all carious tissue was removed while maintaining a thin layer of dentin adjacent to the pulp, and indirect pulp capping was subsequently performed. After confirming the absence of pulp exposure through clinical examination, mineral trioxide aggregate (MTA) was applied to the dentin surface adjacent to the pulp. Direct pulp capping was performed in cases where pulp exposure occurred during caries removal but the clinical and symptomatic findings were consistent with a diagnosis of reversible pulpitis. Following pulp exposure, hemostasis was achieved. After adequate hemostasis was obtained, MTA was applied to the exposed pulp tissue. Permanent coronal restoration of all teeth were performed.

vital pulp therapy

Root canal treatment procedure based on the total score obtained from the Youden symptom scoring system OTHER

All procedures were performed under rubber dam isolation, in a single visit, and by a single operator. For root canal treatment, pulp extirpation was performed after access cavity preparation and canals were shaped with rotary nickel-titanium instruments. A standardized irrigation protocol was applied using 2.5% sodium hypochlorite during and after instrumentation, followed by 17% EDTA for smear layer removal. All irrigants were activated by passive ultrasonic irrigation in three 20-second cycles. After irrigation, canals were dried with sterile paper points and obturated with gutta-percha and a resin-based sealer using the cold lateral compaction technique. All teeth received permanent coronal restorations.

root canal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Rize, Centre, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulpitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: endodontist

Model Details: a prospective clinical study

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: November 4, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 9, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

TU (1)