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NCT Number: NCT07019298

Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

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.

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Key information

Conditions

Pulpitis Dental Pulp Diseases Jaw Diseases Mouth Diseases Periapical Diseases Periapical Lesions Periapical Pathology Periapical Periodontitis Periodontal Diseases Periodontitis 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

Location status: Recruiting

Location contact

José Aranguren, DDS

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).
  • 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]

+ 39 3487200168

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Jun 13, 2025
Registry last updated
Jun 13, 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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