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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Viet Nam
Specialized Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City.
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Nguyen Le Nguyen, DDS
lenguyenyd@gmail.com
+84935998100
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 11
Treatments
Experimental: Static Guided Endodontic Surgery Group
A single cohort of patients undergoing targeted endodontic surgery assisted by a custom-designed, 3D-printed teeth-supported static surgical guide.
Related Therapeutic Areas
Sponsors
Leads: University of Medicine and Pharmacy at Ho Chi Minh City

This content was sourced from clinicaltrials.gov