Periapical LesionNCT07246512
A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.
A study testing Mineral Trioxide Aggregate and BioCeramic Root Repair Material Fast Set Putty. in people with Periapical Lesion, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study is to compare two biomaterials used for retrograde obturation during apical surgery. This surgery is indicated in healthy patients when root canal treatment (endodontics) has failed to eliminate a periapical lesion (a persistent infection in the root of the tooth). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Lesion
- What is being tested?
- Mineral Trioxide Aggregate and BioCeramic Root Repair Material Fast Set Putty.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2024to 20 Jan 2026
- 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
- Patients over 18 years of age.
- Patients giving consent for surgical intervention, for radiographic evaluation with HCT preoperatively and at least one more time after 12 months, and for participation in the study.
- Medical history not relevant to the diagnosis and surgical treatment (ASA classes I and II).
- Previous non-surgical endodontic treatment or retreatment with clinical and/or radiographic evidence of persistence or recurrence of apical periodontitis. The minimum time since the last non-surgical treatment shall be 6 months.
- Teeth not previously treated with periapical surgery.
- Lesion less than 10 mm in diameter.
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- Restorable teeth.
- Periodontally sound teeth or teeth with treated periodontal pathology (mobility 1, probing depth < 5mm).
- Teeth with no root resorption.
Who cannot join
- Teeth with vertical fracture.
- Teeth with root perforation.
- Lesions associated with an apicomarginal defect.
- Tunnel lesions.
- Technical errors during surgery that may compromise the outcome.
- Lack of integrity of the dentine walls surrounding the retrograde filling detected with the endoscope.
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- Wound dehiscence.
- Postoperative infection.
- Follow-up less than 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between MTA and TotalFill® BC-RRM Fast Set Putty for Retrograde Filling in Apical Surgery: Randomized Non-inferiority Clinical Trial.
The aim of this study is to compare two biomaterials used for retrograde obturation during apical surgery. This surgery is indicated in healthy patients when root canal treatment (endodontics) has failed to eliminate a periapical lesion (a persistent infection in the root of the tooth).
The main question it seeks to answer is:
Read more
- Is TotalFill® BC-RRM Fast Set Putty more effective than ProRoot® MTA in periapical surgery in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two materials applied as part of the standard surgical procedure. Subsequently, clinical and radiographic follow-up will be performed to assess the degree of healing of the periapical lesion with a 1-year follow-up.
- Conditions
- Periapical Lesion
- Being tested
- Mineral Trioxide Aggregate, BioCeramic Root Repair Material Fast Set Putty.
- Keywords
- periapical lesion, endodontic failure, apical surgery, retrograde filling, periapical healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Trioxide AggregateDevice
Also called MTA, ProRoot® MTA
Trioxide Mineral Aggregate as a retrograde filling material has 3 basic properties: biocompatibility, impermeable sealing of the root canal and properties that facilitate its clinical use. It has excellent properties that contribute to the healing of the periapical lesion.
BioCeramic Root Repair Material Fast Set Putty.Device
Also called BCRRM, TotalFill® BC-RRM Fast Set Putty
BioCeramic Root Repair Material (BCRRM) is a pre-mixed, easy to handle material that has demonstrated properties equivalent to MTA in terms of periapical lesion healing.
| Study group | Role | What they receive |
|---|---|---|
| MTA (Mineral Trioxide Aggregate) | Active comparator | Patients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA). Receives: Device: Mineral Trioxide Aggregate |
| BioCeramic Root Repair Material Fast Set Putty (BCRRM) | Experimental | Patients undergoing apical surgery treated with retrograde obturation using BioCeramic Root Repair Material Fast Set Putty (BCRRM). Receives: Device: BioCeramic Root Repair Material Fast Set Putty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical lesion healing assessed by CBCT using 3D PENN criteria.
Periapical healing will be evaluated using cone-beam computed tomography (CBCT) at 12 months after periapical surgery. Lesion volume or dimensions will be measured and the percentage of reduction will be calculated. Based on these measurements, healing will be classified according to the 3D PENN CBCT criteria into complete, limited, uncertain, or unsatisfactory healing. A comparison will be made between ProRoot® MTA versus TotalFill® BC-RRM Fast Set Putty as retrograde filling materials.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start8 Feb 2024
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246512
- Sponsor's protocol ID
- 1. UV-INV_ETICA-1427893
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Considerations about sharing individual participant data are ongoing. Any future data sharing will adhere to all institutional policies to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between MTA and TotalFill® BC-RRM Fast Set Putty for Retrograde Filling in Apical Surgery: Randomized Non-inferiority Clinical Trial.
- ClinicalTrials.gov ID
- NCT07246512
- Acronym / sponsor ID
- 1. UV-INV_ETICA-1427893
- Conditions
- Periapical Lesion
- Keywords
- periapical lesion, endodontic failure, apical surgery, retrograde filling, periapical healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 24 Nov 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.
The aim of this study is to compare two biomaterials used for retrograde obturation during apical surgery. This surgery is indicated in healthy patients when root canal treatment (endodontics) has failed to eliminate a periapical lesion (a persistent infection in the root of the tooth).
The main question it seeks to answer is:
- Is TotalFill® BC-RRM Fast Set Putty more effective than ProRoot® MTA in periapical surgery in terms of the degree of healing?
The study will include patients who need this type of surgery and meet specific clinical criteria. Each patient will have one of the two materials applied as part of the standard surgical procedure. Subsequently, clinical and radiographic follow-up will be performed to assess the degree of healing of the periapical lesion with a 1-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA (Mineral Trioxide Aggregate) | Active comparator | Device: Mineral Trioxide AggregatePatients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA). |
| BioCeramic Root Repair Material Fast Set Putty (BCRRM) | Experimental | Device: BioCeramic Root Repair Material Fast Set Putty.Patients undergoing apical surgery treated with retrograde obturation using BioCeramic Root Repair Material Fast Set Putty (BCRRM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients over 18 years of age.
- Patients giving consent for surgical intervention, for radiographic evaluation with HCT preoperatively and at least one more time after 12 months, and for participation in the study.
- Medical history not relevant to the diagnosis and surgical treatment (ASA classes I and II).
- Previous non-surgical endodontic treatment or retreatment with clinical and/or radiographic evidence of persistence or recurrence of apical periodontitis. The minimum time since the last non-surgical treatment shall be 6 months.
- Teeth not previously treated with periapical surgery.
Key exclusion criteria (9 listed)
- Teeth with vertical fracture.
- Teeth with root perforation.
- Lesions associated with an apicomarginal defect.
- Tunnel lesions.
- Technical errors during surgery that may compromise the outcome.
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 |
|---|---|---|
| Mineral Trioxide AggregateAlso: MTA, ProRoot® MTATrioxide Mineral Aggregate as a retrograde filling material has 3 basic properties: biocompatibility, impermeable sealing of the root canal and properties that facilitate its clinical use. It has excellent properties that contribute to the healing of the periapical lesion. | Device | MTA (Mineral Trioxide Aggregate) |
| BioCeramic Root Repair Material Fast Set Putty.Also: BCRRM, TotalFill® BC-RRM Fast Set PuttyBioCeramic Root Repair Material (BCRRM) is a pre-mixed, easy to handle material that has demonstrated properties equivalent to MTA in terms of periapical lesion healing. | Device | BioCeramic Root Repair Material Fast Set Putty (BCRRM) |
Primary outcome
Periapical lesion healing assessed by CBCT using 3D PENN criteria.
Time frame: 12 months post-surgery
Periapical healing will be evaluated using cone-beam computed tomography (CBCT) at 12 months after periapical surgery. Lesion volume or dimensions will be measured and the percentage of reduction will be calculated. Based on these measurements, healing will be classified according to the 3D PENN CBCT criteria into complete, limited, uncertain, or unsatisfactory healing. A comparison will be made between ProRoot® MTA versus TotalFill® BC-RRM Fast Set Putty as retrograde filling materials.
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided. Considerations about sharing individual participant data are ongoing. Any future data sharing will adhere to all institutional policies to ensure participant confidentiality.
Related trials for Periapical Lesion
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Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
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A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
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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 Mineral Trioxide Aggregate and BioCeramic Root Repair Material Fast Set Putty. in people with Periapical Lesion, run by University of Valencia at 1 site in Spain.
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 9 inclusion and 9 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 13 Jul 2026. 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 Spain. 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 lesion healing assessed by CBCT using 3D PENN criteria. (time frame: 12 months post-surgery). 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 13 Jul 2026.