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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AH Plus + Continuous Wave Condensation | Active Comparator | Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha |
|
| AH Plus + Single Cone | Active Comparator | Root canal obturation using AH Plus and the single cone technique with cold gutta-percha. |
|
| NeoSealer Flo + Continuous Wave | Experimental | Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique. |
|
| NeoSealer Flo + Single Cone | Experimental | Root canal obturation using NeoSealer Flo and the single cone technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum 6 months after root canal treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum 6 months after treatment |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Malvicini, DDS | Contact | + 39 3487200168 | giulia.malvicini@student.unisi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Recruiting | Madrid | Spain | 28922 | Spain |
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| 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. |
|
| 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. |
| Minimum 6 months after treatment |
| ID | Term |
|---|---|
| D011671 | Pulpitis |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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