Postoperative Pain Evaluation After Obturation With Different Sealers

Not Applicable

Recruiting

• Conditions: Periapical Periodontitis; Pulpitis; Necorsis

• Registration Number: NCT07018284
• Lead Sponsor: University of Siena

Brief Summary

This study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. Teeth will be obturated using either bioceramic or resin-based sealers. The primary objective is to determine whether the type of sealer significantly influences the level of postoperative pain as reported by patients. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at three time points: immediately after treatment, 24 hours, and 72 hours postoperatively. The findings are expected to provide clinical insight into which obturation material may be more effective in minimizing postoperative discomfort.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage.

Exclusion Criteria

• Patients with systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunosuppression).
• Asymptomatic presentation
• Teeth with root fractures, resorption, or open apices.
• Incomplete clinical or radiographic records.
• Cases with poor-quality radiographs or lack of standardization for evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiographic Success Based on Periapical Index (PAI) Criteria	Minimum 6 months after root canal treatment	Radiographic outcome will be assessed using the Periapical Index (PAI) by Ørstavik et al. (1986), which categorizes periapical healing from 1 (normal periapical structures) to 5 (severe apical periodontitis). Success is defined as PAI scores of 1 or 2 (complete healing or healing in progress). Evaluations will be based on periapical radiographs (and CBCT when available) taken at follow-up after at least 6 months. The assessment will be performed by a calibrated blinded evaluator using reference radiographs.

Secondary Outcome Measures

Name	Time	Method
Clinical Success Based on Absence of Symptoms	Minimum 6 months after treatment	Clinical success will be defined by the absence of pain, tenderness to percussion or palpation, swelling, mobility, and other signs of persistent infection. These parameters will be evaluated through standard clinical examination during follow-up visits.
Radiographic Success Based on CBCT Evaluation	Minimum 6 months after treatment	When available, cone beam computed tomography (CBCT) images will be used to assess periapical healing. A modified periapical index (PAI-CBCT) will be used, evaluating the presence, size, and resolution of periapical radiolucencies. Lesion healing will be interpreted as success if there is full resolution or significant reduction in size compared to baseline.

Trial Locations

Locations (1)

Universidad Rey Juan Carlos , Madrid, Spain 28922; 🇪🇸 Madrid, Spain