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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

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
NameTimeMethod
Radiographic Success Based on Periapical Index (PAI) CriteriaMinimum 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
NameTimeMethod
Clinical Success Based on Absence of SymptomsMinimum 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 EvaluationMinimum 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

Universidad Rey Juan Carlos
🇪🇸Madrid, Spain
José Aranguren, DDS
Contact
Spain: +34 617352993
josearanguren@hotmail.com

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