Active — Not RecruitingNot 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 range18 Years

SexALL

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.

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