Necorsis, Periapical Periodontitis, Pulpitis
Conditions
Keywords
Bioceramic sealers, Resin-based sealers, Endodontics
Brief summary
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.
Interventions
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
PROCEDURENeoSealer Flo
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.
PROCEDUREContinuous Wave Condensation
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.
PROCEDURESingle Cone Technique
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
Sponsors
Universidad Rey Juan Carlos
University of Siena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Success Based on Periapical Index (PAI) Criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Based on Absence of Symptoms | 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. |
| Radiographic Success Based on CBCT Evaluation | 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. |
Countries
Spain
Contacts
Primary ContactGiulia Malvicini, DDS
Outcome results
None listed