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| Name | Class |
|---|---|
| Universidad Rey Juan Carlos | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: 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 |
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| Active Comparator: AH Plus + Single Cone | Experimental | Root canal obturation using AH Plus and the single cone technique with cold gutta-percha. |
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| NeoSealer Flo + Continuous Wave | Experimental | Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique. |
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| 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 | Italia: +39 3487200168 | giulia.malvicini@student.unisi.it |
| Name | Affiliation | Role |
|---|---|---|
| José Aranguren, MsC | Universidad Rey Juan Carlos , Madrid, Spain 28922 | Study Director |
| Simone Grandini, PhD | University of Siena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos , Madrid, Spain 28922 | Recruiting | Madrid | 28922 | Spain |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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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. |
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| 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 |
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| 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 |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |