Health TrialsbyHealthPanel

Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

ConditionsPulpitisPeriapical LesionsPeriapical PeriodontitisPeriapical Pathology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Siena

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

270 Participants
are divided into 4 treatment groups
Group A: AH Plus + Continuous Wave CondensationActive comparator 2 interventions
Group B: AH Plus + Single ConeActive comparator 2 interventions
Group C: NeoSealer Flo + Continuous WaveExperimental treatment 2 interventions
Group D: NeoSealer Flo + Single ConeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic Success Based on Periapical Index (PAI) Criteria

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.

Time frame
Minimum 6 months after root canal treatment

Secondary outcomes

1

Clinical Success Based on Absence of Symptoms

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.

Time frame
Minimum 6 months after treatment
2

Radiographic Success Based on CBCT Evaluation

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.

Time frame
Minimum 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Siena

Lead sponsor

Source ClinicalTrials.gov
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