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RECRUITING

NCT07734987

Accuracy and Healing Outcomes of Endodontic Surgery Using a Static Surgical Guide.

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the surgical accuracy and healing outcomes of endodontic surgery performed with the assistance of a 3D-printed static surgical guide in patients requiring apicoectomy. The main questions it aims to answer are: 1. What is the level of positional and angular accuracy of the actual root-end resection compared to the virtual planning when utilizing a static surgical guide? 2. What are the postoperative pain and swelling levels reported by patients at 1, 3, and 7 days after undergoing guided endodontic surgery? 3. What are the clinical success rates and CBCT-based radiographic healing outcomes at 6 months postoperatively? Participants will: * Undergo a preoperative digital workflow combining CBCT data and intraoral surface scans to design a customized static surgical guide. * Undergo targeted endodontic surgery where a 4.5-mm trephine bur is guided through the static template to perform the osteotomy and a 3-mm root-end resection in a single step. * Receive retrograde root-end cavity preparation via ultrasonic tips and root-end filling using calcium aluminosilicate bioceramic paste (Well-Root PT). * Complete self-evaluation forms regarding pain and swelling on postoperative days 1, 3, and 7. * Return for follow-up examinations at 1 week (for suture removal) and at 6 months for definitive clinical evaluations, as well as follow-up multi-planar CBCT imaging to evaluate both periapical bone healing and surgical accuracy via superimposition with the baseline preoperative plan.

Official title: Evaluation of the Accuracy and Healing Outcomes of Endodontic Surgery Using a Static Surgical Guide: A Prospective Longitudinal Cohort Clinical Trial.

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2027-09

Last Updated

2026-07-29

Healthy Volunteers

Conditions

Periapical Periodontitis Periradicular Lesion Endodontic Treatment Failure Postoperative Wound Healing

Interventions

DEVICE

3D-Printed Static Surgical Guide and Trephine Bur

A personalized dental template constructed from surgical guide clear resin via SLA technology, incorporating a guide sleeve to orient a 4.5-mm trephine bur for single-step cortical plate perforation and 3-mm root-end resection.

DEVICE

Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation

Preparation of a 3-mm deep root-end cavity using specialized ultrasonic tips driven by a piezo-ultrasonic surgical unit, followed by retrograde obturation with Well-Root PT calcium aluminosilicate bioceramic paste

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.

Locations (1)

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

Ho Chi Minh City, Vietnam