Diagnostic Validity of a Quantitative Pulp Pain Scoring System and Its Association With Postoperative Clinical Outcomes: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Diagnostic concordance of the Pulp Pain Assessment Tool (PPAT) with established pulpal diagnostic systems
研究概览
简要总结
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.
详细描述
Material and methods This prospective, single-center observational clinical study aimed to evaluate the diagnostic concordance of a quantitative symptom-based scoring system for pulpal symptom severity and its association with patient-centered clinical outcomes. Ethical approval was obtained from the Recep Tayyip Erdoğan University Non-Interventional Clinical Research Ethics Committee (2025/435), and written informed consent was obtained from all participants.
The study was conducted at the Department of Endodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University. All consecutive patients presenting with acute dental complaints were screened, and those meeting the predefined inclusion criteria were enrolled following clinical and radiographic examinations.
Patient selection Eligible participants were adults (≥18 years) presenting with acute symptoms related to a single vital tooth without clinical or radiographic evidence of periapical pathology. Exclusion criteria included pulpal necrosis, previously root canal-treated teeth, non-pulpal periapical pathology, regular use of analgesic or anti-inflammatory drugs, pregnancy, immunosuppressive conditions, and systemic diseases affecting pain perception, healing, or follow-up.
Classification of Pulpal Diseases and Diagnostic Criteria Pulpal status was independently evaluated at the time of presentation using three diagnostic approaches.
Wolters Diagnostic Classification Pulpal inflammation was classified according to the four-level system proposed by Wolters et al. as initial, mild, moderate, or severe pulpitis, based on the biological continuity and severity of symptoms [4]. Initial and mild pulpitis-characterized by reversible, stimulus-related pain without significant spontaneous symptoms-were categorized as reversible pulpitis, whereas moderate and severe pulpitis-defined by intense, prolonged, and often spontaneous pain affecting daily activities-were categorized as irreversible pulpitis. This classification was based on clinical parameters including response duration to thermal stimuli, spontaneous pain, analgesic requirement, and impact on daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older presenting with acute symptoms associated with a single tooth exhibiting vital pulp tissue, without clinical or radiographic evidence of periapical pathology, and who consented to participate were included.
排除标准
- •Exclusion criteria comprised pulpal necrosis, previously root canal-treated teeth, periapical pathology unrelated to pulpal disease, regular use of analgesic or anti-inflammatory medications, pregnancy, immunosuppressive conditions, and systemic diseases that could interfere with pain perception, healing, or follow-up compliance.
研究组 & 干预措施
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.
干预措施: Vital pulp therapy procedure based on the total score obtained from the Youden symptom scoring system (Other)
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.
干预措施: Root canal treatment procedure based on the total score obtained from the Youden symptom scoring system (Other)
结局指标
主要结局
Diagnostic concordance of the Pulp Pain Assessment Tool (PPAT) with established pulpal diagnostic systems
时间窗: At baseline (at the time of patient presentation, prior to treatment)
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.
次要结局
- Postoperative pain intensity(Up to 7 days after treatment)
研究者
Medine Ciçek
endodontist
Recep Tayyip Erdogan University