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Diagnostic Agreement, Postoperative Pain, and Vital Pulp Therapy Outcomes: A Prospective Clinical Evaluation of 11-Item Pulp Pain Assessment Tool

5 listopada 2026 zaktualizowane przez: Medine Ciçek, Recep Tayyip Erdogan University

Diagnostic Agreement, Postoperative Pain, and Vital Pulp Therapy Outcomes

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.

Przegląd badań

Szczegółowy opis

This prospective, single-center clinical study was designed to evaluate the diagnostic performance of the 11-item Pulp Pain Assessment Tool (PPAT-11) and its agreement with established clinical classifications of pulpitis. The study also investigated the relationship between baseline PPAT-11 scores and postoperative clinical outcomes, including pain, analgesic consumption, and long-term outcomes following vital pulp therapy (VPT).

Pulpal status was assessed before treatment using three approaches: the American Association of Endodontists (AAE) classification, the Wolters classification, and PPAT-11. Assessments were conducted face-to-face by an experienced endodontist using a standardized sequence. The PPAT-11 generates a cumulative score ranging from 11 to 44, with higher scores indicating greater symptom burden. The previously proposed cut-off score of 25 was applied without recalibration.

Treatment allocation was determined by the prespecified PPAT-11 threshold. Patients scoring below 25 underwent VPT, consisting of direct or indirect pulp capping according to clinical findings, whereas patients scoring 25 or higher received root canal treatment (RCT). All treatments were performed by the same operator in a single visit under rubber dam isolation using standardized clinical procedures.

Postoperative assessments included patient-reported pain intensity and analgesic consumption during the first seven days. Patients who underwent VPT received additional clinical and radiographic follow-up at 6 and 12 months to evaluate treatment outcomes.

The study was intended to investigate whether PPAT-11 could provide complementary quantitative information regarding pulpal symptom severity and whether baseline scores were associated with postoperative symptoms and subsequent VPT outcomes. Diagnostic agreement, longitudinal postoperative pain, analgesic consumption, and long-term VPT outcomes were evaluated using appropriate statistical methods.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

143

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Centre
      • Rize, Centre, Turcja (Türkiye), 53020
        • Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Patients presenting with acute dental pain attributable to a single vital tooth.
  • Absence of periapical pathology.
  • Ability to provide reliable responses during clinical and pain assessments.
  • Provision of written informed consent.

Exclusion Criteria:

  • Pulp necrosis.
  • Previous root canal treatment of the affected tooth.
  • Use of analgesic or anti-inflammatory medications within 24 hours before assessment.
  • Antibiotic or systemic corticosteroid therapy affecting clinical symptoms.
  • Pregnancy.
  • Immunosuppressive conditions.
  • Inability to provide reliable clinical responses.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: vital pulp therapy

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.

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.

Eksperymentalny: root canal treatment

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.

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic agreement of PPAT-11 with established pulpal diagnostic classifications
Ramy czasowe: Baseline (before treatment)

Diagnostic agreement between the 11-item Pulp Pain Assessment Tool (PPAT-11) and the American Association of Endodontists (AAE) and Wolters classifications, evaluated using Cohen's kappa coefficient. PPAT-11 scores below 25 and scores of 25 or higher were classified as reversible and irreversible pulpitis, respectively.

Baseline (before treatment)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Postoperative pain intensity
Ramy czasowe: Up to 7 days after treatment

Postoperative pain intensity assessed using a 0-100 mm visual analogue scale (VAS). Patients recorded the maximum pain experienced during six postoperative intervals: 0-8, 8-24, 24-48, 48-72, 72-120, and 120-168 hours.

Up to 7 days after treatment
Postoperative analgesic consumption
Ramy czasowe: Up to 7 days after treatment

Analgesic use recorded during the first 7 days after treatment, assessed as the proportion of patients reporting any analgesic consumption.

Up to 7 days after treatment
Clinical and radiographic success of vital pulp therapy
Ramy czasowe: 6 and 12 months after treatment

Clinical and radiographic success of vital pulp therapy assessed according to symptoms, pulp sensibility responses, clinical and radiographic findings, and the need for further endodontic intervention.

6 and 12 months after treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 listopada 2025

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2026

Ukończenie studiów (Rzeczywisty)

2 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

9 stycznia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 stycznia 2026

Pierwszy wysłany (Rzeczywisty)

16 stycznia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 listopada 2026

Ostatnia weryfikacja

1 stycznia 2026

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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