Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements
- Conditions
- PulpitisPeriapical LesionsPeriapical PeriodontitisPeriapical 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage.
- 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.
Related Research Topics
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Trial Locations
- Locations (1)
Universidad Rey Juan Carlos
🇪🇸Madrid, Spain
Universidad Rey Juan Carlos🇪🇸Madrid, SpainJosé Aranguren, DDSContactSpain: +34 617352993josearanguren@hotmail.com