Healing Outcomes Following Hydraulic Condensation With a Bioactive Bioceramic Sealer in Root Canal Treatment

NCT ID: NCT07075354

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-01-20

Brief Summary

This prospective clinical study aimed to evaluate the healing outcomes after root canal treatment using a bioceramic sealer called BioRoot RCS in combination with a technique known as hydraulic condensation. Root canal treatment is a common procedure used to remove infection and preserve teeth. Bioceramic materials have recently gained attention due to their ability to support natural healing, form a strong seal in the root canal, and stimulate tissue regeneration.

A total of 66 permanent teeth from patients diagnosed with either irreversible pulpitis or apical periodontitis were treated and followed over a 12-month period. All treatments were completed in a single visit and followed a standardized protocol using sonic irrigation and a calibrated drying method. The sealer used-BioRoot RCS-is a bioactive, calcium silicate-based material that hardens in the presence of moisture and promotes healing.

Patients were monitored clinically and radiographically using the Periapical Index (PAI), which is a scale that measures the status of periapical tissue (area around the root tip). Healing was considered successful if the treated teeth remained symptom-free and showed favorable radiographic changes over time.

Detailed Description

This prospective single-arm clinical study was designed to evaluate the healing outcomes following root canal treatment performed using a calcium silicate-based bioceramic sealer (BioRoot™ RCS) in conjunction with the hydraulic condensation obturation technique. The protocol emphasized clinical standardization, with all treatments completed in a single visit by experienced endodontists under magnification.

Following local anesthesia and rubber dam isolation, root canals were prepared using rotary nickel-titanium instrumentation to a standardized apical size (generally ISO 35-45 depending on canal anatomy), and irrigation was performed with 5.25% sodium hypochlorite (NaOCl) activated with a sonic device (EndoActivator, Dentsply Sirona). A final rinse protocol included 17% EDTA and saline, followed by calibrated drying with a single paper point to ensure optimal moisture conditions for the setting of the bioceramic sealer.

BioRoot RCS was mixed according to the manufacturer's instructions and delivered into the canals using a dedicated syringe tip. A single-cone gutta-percha point matching the apical preparation size was inserted with slight apical pressure to displace excess sealer, completing the hydraulic condensation process. No thermoplasticized techniques or heat sources were used to preserve the bioactive potential of the sealer.

Postoperative radiographs were taken immediately and at recall intervals of 6 and 12 months. Clinical and radiographic evaluations were conducted using the Periapical Index (PAI), with scoring by two calibrated examiners blinded to the clinical data. Inter-examiner agreement was assessed using Cohen's kappa.

The primary endpoint was periapical healing, operationally defined as a reduction in PAI score and the absence of symptoms. Comparative analysis was also performed between teeth with and without baseline periapical pathology to assess differential healing responses.

Conditions

Irreversible Pulpitis; Apical Periodontitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydraulic Condensation with BioRoot RCS

This arm involves root canal treatment using the hydraulic condensation technique combined with BioRoot RCS, a bioceramic calcium silicate-based sealer. The procedure includes standardized irrigation with sonic activation, drying using a single calibrated paper point without alcohol, and single-visit obturation. BioRoot RCS sets hydraulically in the presence of moisture, promotes hard tissue formation, and provides a durable seal to support periapical healing.

Group Type: EXPERIMENTAL

Hydraulic Condensation Root Canal Obturation with BioRoot RCS

Intervention Type: PROCEDURE

Root canal obturation using the hydraulic condensation technique combined with BioRoot RCS, a bioceramic calcium silicate-based sealer. Treatment includes standardized irrigation with sonic activation and drying using a single calibrated paper point without alcohol. The sealer sets hydraulically in the presence of moisture, promotes hard tissue formation, and provides a durable, bioactive seal supporting periapical healing.

Interventions

Hydraulic Condensation Root Canal Obturation with BioRoot RCS

Root canal obturation using the hydraulic condensation technique combined with BioRoot RCS, a bioceramic calcium silicate-based sealer. Treatment includes standardized irrigation with sonic activation and drying using a single calibrated paper point without alcohol. The sealer sets hydraulically in the presence of moisture, promotes hard tissue formation, and provides a durable, bioactive seal supporting periapical healing.

Intervention Type: PROCEDURE

Other Intervention Names

BioRoot RCS bioceramic sealer; Calcium silicate-based root canal sealer

Eligibility Criteria

Inclusion Criteria

permanent teeth patients aged over 18 years both biological genders good general health, teeth diagnosed with irreversible pulpitis or apical periodontitis

Exclusion Criteria

teeth with previous root canal treatment, teeth with open apices (immature teeth), teeth with extensive resorption, teeth with severe periodontal disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Plovdiv Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Plovdiv, Faculty of Dental Medicine, Department of Operative Dentistry and Endodontics

Plovdiv, Plovdiv, Bulgaria

Countries

Bulgaria

Other Identifiers

MU-Endo-HCBR2021-01

Identifier Type: -

Identifier Source: org_study_id