Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

NCT ID: NCT07019298

Last Updated: 2025-06-13

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

2029-06-01

Brief Summary

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The present study aims to compare the radiographic success of endodontic treatment using Orstavik's criteria between two sealers: AH Plus (Dentsply DeTrey, Konstanz, Germany) and Neosealer Flo (Avalon Biomed, Bradenton, Florida, USA), as well as between two obturation techniques: continuous wave and single cone. The study includes 270 patients, with a minimum follow-up period of 6 months. Clinical and radiographic variables will be assessed, including quality of obturation, lesion healing, and restoration. The study seeks to determine if the use of bioceramic sealer is effective regardless of the obturation technique used, highlighting the importance of clinical follow-up to evaluate endodontic treatment success.

Detailed Description

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Conditions

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Pulpitis Periapical Lesions Periapical Periodontitis Periapical Pathology

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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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.

AH Plus + Single Cone

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

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).
* 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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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Simone Grandini

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Rey Juan Carlos

Madrid, Spain, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Giulia Malvicini, DDS

Role: CONTACT

+ 39 3487200168

Facility Contacts

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José Aranguren, DDS

Role: primary

Spain: +34 617352993

Other Identifiers

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HCCWC001

Identifier Type: -

Identifier Source: org_study_id

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