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Recruiting Not applicable

Postoperative Pain Evaluation After Obturation With Different Sealers

NCT07018284 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-06-12

Condition(s) studied

Periapical PeriodontitisPulpitisNecorsis

Investigational drug(s) / intervention(s)

AH Plus (Dentsply Sirona, Charlotte, NC, USA)NeoSealer FloContinuous Wave CondensationSingle Cone Technique

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

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.

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.

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Universidad Rey Juan Carlos , Madrid, Spain 28922 Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07018284 on ClinicalTrials.gov ↗ ← All trials in Spain