RecruitingNot ApplicableNCT07734987

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

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


Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Enrollment

11 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 3D-Printed Static Surgical Guide and Trephine Bur and a medical device called Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation for people with endodontic treatment failure, periapical periodontitis, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3D-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.

DEVICEUltrasonic 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


Locations(1)

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

Ho Chi Minh City, Vietnam

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NCT07734987


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