Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

Not Applicable

Recruiting

• Conditions: Pulpitis; Periapical Lesions; Periapical Periodontitis; Periapical Pathology

• Registration Number: NCT07019298
• Lead Sponsor: University of Siena

Brief Summary

The present study aims to compare the radiographic success of endodontic treatment using Orstavik's criteria between two sealers: AH Plus (Dentsply DeTrey, Konstanz, Germany) and Neosealer Flo (Avalon Biomed, Bradenton, Florida, USA), as well as between two obturation techniques: continuous wave and single cone. The study includes 270 patients, with a minimum follow-up period of 6 months. Clinical and radiographic variables will be assessed, including quality of obturation, lesion healing, and restoration. The study seeks to determine if the use of bioceramic sealer is effective regardless of the obturation technique used, highlighting the importance of clinical follow-up to evaluate endodontic treatment success.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-01-01
• Study Completion: 2029-06-01

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).
• 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