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.
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.
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.
Single group
3D-Printed Static Surgical Guide and Trephine Bur
DeviceA 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.
Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation
DevicePreparation 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
Linear Positional Deviation of Apicoectomy
The absolute vertical distance deviation (measured in millimeters) between the virtually planned root-end resection path and the actual resection plane achieved clinically. This measurement is quantified by superimposing the 6-month postoperative CBCT data onto the baseline preoperative planning model.
Angular Deviation of Apicoectomy
The angular difference (measured in degrees) between the long axis of the planned virtual surgical trajectory and the actual surgical track created by the trephine bur, measured across the structural plane containing the root axis
Postoperative Pain Scores
Patient-reported pain intensity measured via a 6-point modified Visual Analog Scale (VAS) where 0 indicates no pain and 5 indicates severe, incapacitating pain requiring complete bed rest.
Postoperative Swelling Scores
Patient-reported tissue swelling measured via a 6-point modified VAS where 0 indicates no swelling and 5 indicates severe facial swelling accompanied by limited mouth opening (trismus).
Volumetric Change of Periapical Lesion
The quantitative volumetric reduction of the periapical radiolucency (calculated in cubic millimeters, mm³) determined by comparative three-dimensional rendering software on CBCT scans acquired at baseline and follow-up. \[Time Frame: Baseline and 6 months postoperatively\]
Clinical Healing Success Status
The proportion of cases achieving 'Complete Clinical Healing' defined according to the Gutmann \& Harrison (1994) criteria, requiring the total absence of pain, clinical tenderness to percussion or palpation, sinus tract formation, pathologic tooth mobility, or deep localized periodontal pockets.
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