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

NCT07075354 | Completed

• 1 other identifier: MU-Endo-HCBR2021-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis; Apical Periodontitis

Keywords

bioceramic sealer; BioRoot RCS; hydraulic condensation; periapical healing; PAI

Outcome Measures

Primary Outcomes (1)

• Periapical Healing Assessed by Periapical Index (PAI) Score

  Radiographic assessment of periapical healing using the Periapical Index (PAI) scoring system on standardized periapical radiographs. Successful healing is defined as a reduction in PAI score indicating resolution or significant improvement of apical periodontitis.

  Baseline, 6 months, and 12 months post-treatment

Study Arms (1)

Hydraulic Condensation with BioRoot RCS

EXPERIMENTAL

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.

Procedure: Hydraulic Condensation Root Canal Obturation with BioRoot RCS

Interventions

Hydraulic Condensation Root Canal Obturation with BioRoot RCS 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.

Also known as: BioRoot RCS bioceramic sealer, Calcium silicate-based root canal sealer

Hydraulic Condensation with BioRoot RCS

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

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

Plovdiv, Plovdiv, 4000, Bulgaria

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-group assignment interventional study assessing the healing outcomes of root canal treatment using hydraulic condensation with the bioceramic sealer BioRoot RCS. All participants receive the same standardized treatment protocol and are followed prospectively for 12 months.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: January 20, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The individual participant data (IPD) and supporting documentation will be available starting 6 months after publication of the main study results and will remain accessible for a period of 5 years.
• Access Criteria: Qualified researchers who submit a reasonable research proposal will be granted access to de-identified IPD and supporting materials. Requests will be reviewed by the study investigators and institutional review board to ensure ethical use and protection of participant privacy. Data will be shared via a secure data transfer platform following signing of a data use agreement.

Locations

BU (1)