A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.

November 17, 2025 updated by: David Peñarrocha Oltra, University of Valencia

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:

- 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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Restorable teeth.
  • Periodontally sound teeth or teeth with treated periodontal pathology (mobility 1, probing depth < 5mm).
  • Teeth with no root resorption.

Exclusion Criteria:

  • 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.
  • Wound dehiscence.
  • Postoperative infection.
  • Follow-up less than 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MTA (Mineral Trioxide Aggregate)
Patients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA).
Device: Mineral Trioxide Aggregate
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.
Other Names:
  • MTA
  • ProRoot® MTA
Experimental: BioCeramic Root Repair Material Fast Set Putty (BCRRM)
Patients undergoing apical surgery treated with retrograde obturation using BioCeramic Root Repair Material Fast Set Putty (BCRRM).
Device: BioCeramic Root Repair Material 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.
Other Names:
  • BCRRM
  • TotalFill® BC-RRM Fast Set Putty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1. UV-INV_ETICA-1427893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Considerations about sharing individual participant data are ongoing. Any future data sharing will adhere to all institutional policies to ensure participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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