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

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.

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Key information

Conditions

Periapical Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MTA, ProRoot® MTA

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.

Other names: BCRRM, TotalFill® BC-RRM Fast Set Putty

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Comparison Between MTA and TotalFill® BC-RRM Fast Set Putty for Retrograde Filling in Apical Surgery: Randomized Non-inferiority Clinical Trial.

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Nov 24, 2025
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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