Postoperative Pain Evaluation After Obturation With Different Sealers
Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers
1 other identifier
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedJune 12, 2025
June 1, 2025
7 months
June 4, 2025
June 4, 2025
Conditions
Keywords
Outcome Measures
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.
Minimum 6 months after root canal treatment
Secondary Outcomes (2)
Clinical Success Based on Absence of Symptoms
Minimum 6 months after treatment
Radiographic Success Based on CBCT Evaluation
Minimum 6 months after treatment
Study Arms (4)
Active Comparator: AH Plus + Continuous Wave Condensation
ACTIVE COMPARATORRoot canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha
Active Comparator: AH Plus + Single Cone
EXPERIMENTALRoot canal obturation using AH Plus and the single cone technique with cold gutta-percha.
NeoSealer Flo + Continuous Wave
EXPERIMENTALRoot canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique.
NeoSealer Flo + Single Cone
EXPERIMENTALRoot canal obturation using NeoSealer Flo and the single cone technique.
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
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.
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.
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
Eligibility Criteria
You may qualify if:
- Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sienalead
- Universidad Rey Juan Carloscollaborator
Study Sites (1)
Universidad Rey Juan Carlos , Madrid, Spain 28922
Madrid, 28922, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
José Aranguren, MsC
Universidad Rey Juan Carlos , Madrid, Spain 28922
- PRINCIPAL INVESTIGATOR
Simone Grandini, PhD
University of Siena
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 4, 2025
First Posted
June 12, 2025
Study Start
June 1, 2025
Primary Completion
December 30, 2025
Study Completion
January 30, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06