Health TrialsbyHealthPanel

Postoperative Pain Evaluation After Obturation With Different Sealers

ConditionsPeriapical PeriodontitisPulpitisNecorsis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Siena

About this trial

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.

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).

Asymptomatic presentation

Teeth with root fractures, resorption, or open apices.

Incomplete clinical or radiographic records.

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: Active Comparator: AH Plus + Continuous Wave CondensationActive comparator 2 interventions
Group B: Active Comparator: AH Plus + Single ConeExperimental treatment 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

Universidad Rey Juan Carlos

Collaborator

Source ClinicalTrials.gov
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