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Recruiting NCT07019298

Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

No phase Interventional Pulpitis Periapical Lesions Periapical Periodontitis Periapical Pathology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AH Plus (Dentsply Sirona, Charlotte, NC, USA), NeoSealer Flo, Continuous Wave Condensation, Single Cone Technique.
Who it may be relevant to
Registry conditions: Pulpitis, Periapical Lesions, Periapical Periodontitis, Periapical Pathology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Success Rate of Endodontic Treatment Using Different Obturation Techniques and Root Canal Sealer Cements: A Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure AH Plus (Dentsply Sirona, Charlotte, NC, USA)
    Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA), a resin-based sealer with low solubility and shrinkage. Used in combination with gutta-percha for root canal filling.
  • Procedure NeoSealer Flo
    Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA), a premixed bioceramic sealer based on calcium silicate. Used in combination with gutta-percha to enhance apical healing and biocompatibility.
  • Procedure Continuous Wave Condensation
    A warm vertical compaction technique using heat-softened gutta-percha to obturate the canal in three dimensions. Considered the gold standard for achieving dense and homogenous root canal fillings.
  • Procedure Single Cone Technique
    A cold hydraulic condensation technique using a single gutta-percha cone matched to the last rotary file, combined with a high-flow sealer. Designed for simplified obturation with minimal operator variability.

Primary outcome measures

  • Radiographic Success Based on Periapical Index (PAI) Criteria [Time frame: Minimum 6 months after root canal treatment]
Secondary outcome measures (2)
  • Clinical Success Based on Absence of Symptoms [Time frame: Minimum 6 months after treatment]
  • Radiographic Success Based on CBCT Evaluation [Time frame: Minimum 6 months after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad Rey Juan Carlos — Madrid

Identifiers

NCT: NCT07019298 · HCCWC001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗