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
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 143 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- Single masked
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Diagnostic agreement of PPAT-11 with established pulpal diagnostic classifications
Time frame: 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.
Secondary measures
Postoperative pain intensity
Time frame: 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
Time frame: 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
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Recep Tayyip Erdoğan University Faculty of Dentistry, Department of EndodonticsRize, Centre, Turkey (Türkiye)Status unknown
Study team and timeline
- Lead sponsor
- Recep Tayyip Erdogan University
- Study start
- Nov 4, 2025 Actual
- Primary completion
- Jan 1, 2026 Actual
- Study completion
- Nov 2, 2026 Actual
- First posted
- Jan 16, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Diagnostic Agreement, Postoperative Pain, and Vital Pulp Therapy Outcomes
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026
