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

NCT07734987 | Recruiting

• 1 other identifier: 2800/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Static surgical guide, Endodontic surgery, Apicoectomy, Cone Beam Computed Tomography, Trephine bur, Well-Root PT, Structural accuracy, Bone healing outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months postoperatively

• 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

  : 6 months postoperatively

Secondary Outcomes (5)

• Postoperative Pain Scores

  Postoperative days 1, 3, and 7

• Postoperative Swelling Scores

  Postoperative days 1, 3, and 7

• Volumetric Change of Periapical Lesion

  Baseline and 6 months postoperatively

• Clinical Healing Success Status

  6 months postoperatively

• Radiographic Healing Score (CBCT Evaluation)

  6 months postoperatively

Study Arms (1)

Static Guided Endodontic Surgery Group

EXPERIMENTAL

A single cohort of patients undergoing targeted endodontic surgery assisted by a custom-designed, 3D-printed teeth-supported static surgical guide.

Device: 3D-Printed Static Surgical Guide and Trephine Bur; Device: Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation

Interventions

3D-Printed Static Surgical Guide and Trephine Bur DEVICE

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.

Static Guided Endodontic Surgery Group

Ultrasonic Retrograde Preparation and Bioceramic Retrograde Obturation DEVICE

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

Static Guided Endodontic Surgery Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

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

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Son Hoang Le, DDS, PhD

  Department of Oral Surgery, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY DIRECTOR

Central Study Contacts

Nguyen Le Nguyen, DDS

CONTACT

+84935998100; lenguyenyd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Clinical and radiographic outcome assessments will be conducted by an independent dental clinician who was not involved in the surgical procedures. To minimize detection bias, all patient data and CBCT DICOM files will be anonymized and coded prior to evaluation. The assessor will remain blinded to the patients' clinical postoperative profiles (pain and swelling progression) when grading bone healing outcomes.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-arm, prospective clinical trial in which a single cohort of eligible participants consecutively receives targeted endodontic surgery assisted by a 3D-printed static guide, with each patient serving as their own baseline for healing evaluations, and actual surgical paths compared against virtual plans for accuracy assessments.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)