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

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

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
143 Real

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

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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.
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Sin asignación al azar
Enmascaramiento
Enmascaramiento simple
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.

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

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.

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

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.

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Diagnostic agreement of PPAT-11 with established pulpal diagnostic classifications

Plazo: 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.

Medidas secundarias

Postoperative pain intensity

Plazo: 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.

Postoperative analgesic consumption

Plazo: 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.

Clinical and radiographic success of vital pulp therapy

Plazo: 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.

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Centros de investigación (1)

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1 centros

Recep Tayyip Erdoğan University Faculty of Dentistry, Department of EndodonticsRize, Centre, Turkey (Türkiye)Estado desconocido

Equipo y fechas

Patrocinador principal
Recep Tayyip Erdogan University
Inicio del estudio
4 nov 2025 Real
Finalización primaria
1 ene 2026 Real
Finalización del estudio
2 nov 2026 Real
Primera publicación
16 ene 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

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Título oficial del estudio

Diagnostic Agreement, Postoperative Pain, and Vital Pulp Therapy Outcomes

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026