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

Official title

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

Overview

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.

Detailed description

This prospective, single-arm, longitudinal clinical trial evaluates the accuracy and healing results of targeted endodontic surgery guided by 3D-printed static templates. The study aims to determine whether a fully digital workflow can standardize root-end resection, minimize bone removal, and provide favorable clinical outcomes.

Each eligible participant undergoes a standardized preoperative digital preparation. High-definition CBCT imaging data (DICOM format) and intraoral surface scan data (STL format) are acquired and imported into the Realguide software (version 5.0). After precise registration using three anatomical landmarks, the surgical path is planned. A virtual cylinder representing a 4.5-mm diameter trephine bur is positioned perpendicular to the root axis, calculated to achieve an exact 3-mm apicoectomy length. A teeth-supported static surgical guide with a 4.6-mm internal diameter sleeve and verification windows is then designed and fabricated using Stereolithography (SLA) 3D printing technology with biocompatible resin.

On the day of surgery, after administering local anesthesia (2% lidocaine with 1:100,000 epinephrine) and reflecting a full-thickness mucoperiosteal flap, the static surgical guide is securely positioned on the dental arch. Cortical plate osteotomy and root-end resection are executed in a single step through the guide sleeve using a 4.5-mm trephine bur at a speed of 800 rpm under continuous sterile saline irrigation. Following guide removal and periapical lesion debridement, a 3-mm deep retrograde cavity is prepared along the root canal axis using dedicated ultrasonic tips. The root end is then sealed with Well-Root PT bioceramic material, and the flap is secured using 5-0 nylon sutures. Postoperative medications including amoxicillin, ibuprofen, and paracetamol are prescribed uniformly.

Patient-centered outcomes (pain and swelling intensity) are self-recorded using a 6-point modified Visual Analog Scale (VAS) on days 1, 3, and 7 post-surgery. Sutures are removed at day 7. At the 6-month follow-up milestone, patients undergo comprehensive clinical evaluations based on the Gutmann \& Harrison (1994) criteria. Concurrently, a postoperative CBCT scan is performed using identical exposure parameters to quantify periapical lesion volume reduction and grade structural bone healing (cortical plate, resection plane, and peri-radicular space regeneration) according to the Azim (2021) criteria. The cumulative digital data sets are superimposed to calculate the linear distance (mm) and angular deviations (degrees) between the planned and actual surgical paths, thereby establishing the structural accuracy of the static guided technique.

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

Primary outcome measures

• Linear Positional Deviation of Apicoectomy [Time frame: 6 months postoperatively]
• Angular Deviation of Apicoectomy [Time frame: : 6 months postoperatively]

Secondary outcome measures (5)

• Postoperative Pain Scores [Time frame: Postoperative days 1, 3, and 7]
• Postoperative Swelling Scores [Time frame: Postoperative days 1, 3, and 7]
• Volumetric Change of Periapical Lesion [Time frame: Baseline and 6 months postoperatively]
• Clinical Healing Success Status [Time frame: 6 months postoperatively]
• Radiographic Healing Score (CBCT Evaluation) [Time frame: 6 months postoperatively]

Eligibility criteria

Inclusion criteria

• 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.
• The periapical radiolucency features a well-defined maximum radiographic dimension of >= 5 mm on CBCT.
• The target tooth has no history of previous surgical root-end resection procedures.
• The lesion does not directly involve or impinge upon hazardous adjacent anatomical structures (e.g., the inferior alveolar nerve canal, the maxillary sinus floor, or the mental foramen).
• The presence of at least three stable, non-mobile permanent teeth within the same dental arch to serve as reliable anchor units to support the surgical template.
• Patient is fully capable and willing to provide signed written informed consent.

Exclusion criteria

• 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.
• Massive periapical pathology requiring a root-end resection length exceeding 3 mm, or necessitating excessive mechanical field widening beyond the template boundaries to achieve surgical curettage.
• Inadequate stability, rocking, or poor fit of the printed surgical guide during the intraoral verification phase.
• Patient demonstrates non-compliance or is unable to return for scheduled longitudinal follow-ups and imaging appointments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• Specialized Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharm — Ho Chi Minh City

Identifiers

NCT: NCT07734987 · 2800/ĐHYD-HĐĐĐ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗