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Recruiting NCT07018284

Postoperative Pain Evaluation After Obturation With Different Sealers

No phase Interventional Periapical Periodontitis Pulpitis Necorsis

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: Periapical Periodontitis, Pulpitis, Necorsis. 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 →

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Official title

Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers

Overview

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.

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).
  • 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

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, Spain 28922 — Madrid

Identifiers

NCT: NCT07018284 · HSCO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗