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

NCT07734987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-07-29

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Principal Investigators

  • Son Hoang Le, DDS, PhD · Department of Oral Surgery, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734987 on ClinicalTrials.gov