Irreversible PulpitisHEAL-BRNCT07075354
Healing Outcomes Following Hydraulic Condensation With a Bioactive Bioceramic Sealer in Root Canal Treatment
A study testing Hydraulic Condensation Root Canal Obturation with BioRoot RCS in people with Irreversible Pulpitis and Apical Periodontitis, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis, Apical Periodontitis
- What is being tested?
- Hydraulic Condensation Root Canal Obturation with BioRoot RCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBulgaria
- Study dates
- 20 Jan 2021to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- teeth with previous root canal treatment, teeth with open apices (immature teeth), teeth with extensive resorption, teeth with severe periodontal disease
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical University of Plovdiv, Faculty of Dental Medicine, Department of Operative Dentistry and Endodontics
Plovdiv, Plovdiv, 4000
About this study
Official title: Clinical and Radiographic Outcomes of Root Canal Obturation With Hydraulic Condensation and Bioceramic Biomaterial: A 12-Month Prospective Study on Periapical Healing
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.
Read the 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
- Being tested
- Hydraulic Condensation Root Canal Obturation with BioRoot RCS
- Keywords
- bioceramic sealer, BioRoot RCS, hydraulic condensation, periapical healing, PAI
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydraulic Condensation Root Canal Obturation with BioRoot RCSProcedure or surgery
Also called BioRoot RCS bioceramic sealer, Calcium silicate-based root canal sealer
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Hydraulic Condensation Root Canal Obturation with BioRoot RCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start20 Jan 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075354
- Sponsor's protocol ID
- MU-Endo-HCBR2021-01
- Acronym
- HEAL-BR
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Data sharing will follow institutional and ethical guidelines, ensuring participant confidentiality. Access will be granted after publication of the main study results and completion of any necessary data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Root Canal Obturation With Hydraulic Condensation and Bioceramic Biomaterial: A 12-Month Prospective Study on Periapical Healing
- ClinicalTrials.gov ID
- NCT07075354
- Acronym / sponsor ID
- HEAL-BR / MU-Endo-HCBR2021-01
- Conditions
- Irreversible Pulpitis, Apical Periodontitis
- Keywords
- bioceramic sealer, BioRoot RCS, hydraulic condensation, periapical healing, PAI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hydraulic Condensation with BioRoot RCS | Experimental | Procedure: Hydraulic Condensation Root Canal Obturation with BioRoot RCSThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- teeth with previous root canal treatment, teeth with open apices (immature teeth), teeth with extensive resorption, teeth with severe periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydraulic Condensation Root Canal Obturation with BioRoot RCSAlso: BioRoot RCS bioceramic sealer, Calcium silicate-based root canal sealerRoot 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. | Procedure or surgery | Hydraulic Condensation with BioRoot RCS |
Primary outcome
Periapical Healing Assessed by Periapical Index (PAI) Score
Time frame: Baseline, 6 months, and 12 months post-treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Data sharing will follow institutional and ethical guidelines, ensuring participant confidentiality. Access will be granted after publication of the main study results and completion of any necessary data use agreements.
Related trials for Irreversible Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydraulic Condensation Root Canal Obturation with BioRoot RCS in people with Irreversible Pulpitis and Apical Periodontitis, run by Plovdiv Medical University at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periapical Healing Assessed by Periapical Index (PAI) Score (time frame: Baseline, 6 months, and 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.