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NCT Number: NCT07018284

Postoperative Pain Evaluation After Obturation With Different Sealers

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.

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Key information

Conditions

Periapical Periodontitis Dental Pulp Diseases Jaw Diseases Mouth Diseases Necorsis Periapical Diseases Periodontal Diseases Periodontitis Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Rey Juan Carlos , Madrid, Spain 28922

Madrid, 28922, Spain

Location status: Recruiting

Location contact

Jose Aranguren, MsC

CONTACT

[email protected]

Spain: +34 617352993

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AH Plus (Dentsply Sirona, Charlotte, NC, USA)

Procedure

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

Procedure

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

Procedure

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

Procedure

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 outcomes

  1. Radiographic Success Based on Periapical Index (PAI) Criteria

    Time frame: 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 outcomes

  1. Clinical Success Based on Absence of Symptoms

    Time frame: 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.

  2. Radiographic Success Based on CBCT Evaluation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Malvicini, DDS

CONTACT

[email protected]

Italia: +39 3487200168

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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