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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this trial

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 criteria

Qualifiers

Patient is aged 16 years or older.

Patient possesses a healthy or stable systemic physical status classification (ASA I or II).

Presence of at least one permanent tooth displaying a distinct clinical indication for apical endodontic surgery.

The estimated post-resection crown-to-root ratio of the target tooth remains <= 1.

Disqualifiers

Women who are currently pregnant or breastfeeding.

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.

Extensive metal restorations, crowns, or massive fixed partial dentures adjacent to the target site that generate severe radiographic scattering artifacts, compromising CBCT measurement quality.

Target tooth displays clinical evidence of a vertical root fracture, non-restorable structural crown destruction, or advanced localized periodontitis.

Trial design

Treatments tested in this trial

  • 3D-Printed Static Surgical Guide and Trephine Bur
  • Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation

Treatment groups

11 Participants
are divided into 1 treatment group