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

NCT07246512 | Active Not Recruiting FDA Device

• 1 other identifier: 1. UV-INV_ETICA-1427893
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Periapical Lesion

Keywords

periapical lesion; endodontic failure; apical surgery; retrograde filling; periapical healing

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months post-surgery

Study Arms (2)

MTA (Mineral Trioxide Aggregate)

ACTIVE COMPARATOR

Patients undergoing apical surgery treated with retrograde obturation using Mineral Trioxide Aggregate (MTA).

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).

Device: BioCeramic Root Repair Material Fast Set Putty.

Interventions

Mineral Trioxide Aggregate DEVICE

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.

Also known as: MTA, ProRoot® MTA

MTA (Mineral Trioxide Aggregate)

BioCeramic Root Repair Material Fast Set Putty. DEVICE

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.

Also known as: BCRRM, TotalFill® BC-RRM Fast Set Putty

BioCeramic Root Repair Material Fast Set Putty (BCRRM)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, PhD

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: February 8, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-07

Locations

ES (1)