Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

NCT07019298 | Recruiting DMC

• 1 other identifier: HCCWC001
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis; Periapical Lesions; Periapical Periodontitis; Periapical Pathology

Keywords

Endodontics; Endodontic Sealer; Calcium Silicate-Based Sealer; Ah Plus

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)

AH Plus + Continuous Wave Condensation

ACTIVE COMPARATOR

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

Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA); Procedure: Continuous Wave Condensation

AH Plus + Single Cone

ACTIVE COMPARATOR

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

Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA); Procedure: Single Cone Technique

NeoSealer Flo + Continuous Wave

EXPERIMENTAL

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

Procedure: NeoSealer Flo; Procedure: Continuous Wave Condensation

NeoSealer Flo + Single Cone

EXPERIMENTAL

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

Procedure: NeoSealer Flo; Procedure: Single Cone Technique

Interventions

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

AH Plus + Continuous Wave Condensation; AH Plus + Single Cone

NeoSealer Flo 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.

NeoSealer Flo + Continuous Wave; NeoSealer Flo + Single Cone

Continuous Wave Condensation 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 + Continuous Wave Condensation; NeoSealer Flo + Continuous Wave

Single Cone Technique 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.

AH Plus + Single Cone; NeoSealer Flo + Single Cone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• Teeth with root fractures, resorption, or open apices.
• Incomplete clinical or radiographic records.
• Cases with poor-quality radiographs or lack of standardization for evaluation

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, Spain, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Pulpitis; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Giulia Malvicini, DDS

CONTACT

+ 39 3487200168; giulia.malvicini@student.unisi.it

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: May 20, 2025
• First Posted: June 13, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

ES (1)