Accuracy and healing outcomes of endodontic surgery with a 3D-printed static guide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study evaluates the accuracy of root-end resection planned with a digital workflow and performed through a static, teeth-supported guide, along with postoperative pain, swelling, and radiographic healing at six months. Preoperative CBCT and intraoral scans are used to design a customized guide that directs a 4.5-mm trephine bur to a 3-mm apicoectomy. Surgeries are conducted with the guide in place, and outcomes include positional and angular accuracy versus planning, patient-reported postoperative symptoms at days 1, 3, and 7, and CBCT-based healing at 6 months. The study aims to determine whether this fully digital workflow standardizes the procedure and preserves bone while maintaining favorable clinical results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is aged 16 years or older.
2. Patient possesses a healthy or stable systemic physical status classification (ASA I or II).
3. Presence of at least one permanent tooth displaying a distinct clinical indication for apical endodontic surgery.
4. The estimated post-resection crown-to-root ratio of the target tooth remains \<= 1.
5. The periapical radiolucency features a well-defined maximum radiographic dimension of \>= 5 mm on CBCT.
6. The target tooth has no history of previous surgical root-end resection procedures.
7. The lesion does not directly involve or impinge upon hazardous adjacent anatomical structures (e.g., the inferior alveolar nerve canal, the maxillary sinus floor, or the mental foramen).
8. The presence of at least three stable, non-mobile permanent teeth within the same dental arch to serve as reliable anchor units to support the surgical template.
9. Patient is fully capable and willing to provide signed written informed consent.

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding.
2. History of known allergy or systemic hypersensitivity to amide local anesthetics, epinephrine co-agents, or any structural resins and bioceramic materials utilized in this protocol.
3. Extensive metal restorations, crowns, or massive fixed partial dentures adjacent to the target site that generate severe radiographic scattering artifacts, compromising CBCT measurement quality.
4. Target tooth displays clinical evidence of a vertical root fracture, non-restorable structural crown destruction, or advanced localized periodontitis.
5. Massive periapical pathology requiring a root-end resection length exceeding 3 mm, or necessitating excessive mechanical field widening beyond the template boundaries to achieve surgical curettage.
6. Inadequate stability, rocking, or poor fit of the printed surgical guide during the intraoral verification phase.
7. Patient demonstrates non-compliance or is unable to return for scheduled longitudinal follow-ups and imaging appointments.

Where it's running

• Specialized Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City.
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Study coordinator: Nguyen Le Nguyen, DDS
• Email: lenguyenyd@gmail.com
• Phone: +84935998100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.