Postoperative Pain Evaluation After Obturation With Different Sealers

NCT ID: NCT07018284

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periapical Periodontitis Pulpitis Necorsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator: AH Plus + Continuous Wave Condensation

Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha

Group Type ACTIVE_COMPARATOR

AH Plus (Dentsply Sirona, Charlotte, NC, USA)

Intervention Type 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

Continuous Wave Condensation

Intervention Type 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.

Active Comparator: AH Plus + Single Cone

Root canal obturation using AH Plus and the single cone technique with cold gutta-percha.

Group Type EXPERIMENTAL

AH Plus (Dentsply Sirona, Charlotte, NC, USA)

Intervention Type 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

Single Cone Technique

Intervention Type 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

NeoSealer Flo + Continuous Wave

Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique.

Group Type EXPERIMENTAL

NeoSealer Flo

Intervention Type 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

Intervention Type 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.

NeoSealer Flo + Single Cone

Root canal obturation using NeoSealer Flo and the single cone technique.

Group Type EXPERIMENTAL

NeoSealer Flo

Intervention Type 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.

Single Cone Technique

Intervention Type 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

Interventions

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AH Plus (Dentsply Sirona, Charlotte, NC, USA)

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

Intervention Type PROCEDURE

NeoSealer 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.

Intervention Type PROCEDURE

Continuous 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.

Intervention Type PROCEDURE

Single 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role collaborator

University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Simone Grandini

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Aranguren, MsC

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos , Madrid, Spain 28922

Simone Grandini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Locations

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Universidad Rey Juan Carlos , Madrid, Spain 28922

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Giulia Malvicini, DDS

Role: CONTACT

Italia: +39 3487200168

Facility Contacts

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Jose Aranguren, MsC

Role: primary

Spain: +34 617352993

Other Identifiers

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HSCO

Identifier Type: -

Identifier Source: org_study_id

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