Clinical Trial

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

Recruiting
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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.
Trial Details
NCT Number NCT07734987
Lead Sponsor University of Medicine and Pharmacy at Ho Chi Minh City
Conditions Periapical Periodontitis, Periradicular Lesion, Endodontic Treatment Failure, Postoperative Wound Healing
Enrollment 11 participants
Start Date 2026-07-01
Primary Completion 2027-03 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-29