CompletedNot Applicable

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

Spain110 participantsStarted 2024-02-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Periapical lesion healing assessed by CBCT using 3D PENN criteria.

Timeframe: 12 months post-surgery

Trial details

NCT IDNCT07246512

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-20

View on ClinicalTrials.gov More Periapical Lesion trials