NCT06963242

Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis

Accuracy of Dynamic Navigation System in Implant Surgery for Full Arch Prosthesis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study Objective: This study aims to evaluate the accuracy of the Dynamic Navigation System in performing implant placement for full arch prosthesis rehabilitation. This system uses landmarks, including bone screws fixed to the bone (Group 1), and landmarks on remaining teeth to be extracted (Group 2), to accurately determine the placement of the implants Participants: Patients aged 18 and older, who have total tooth loss or partial tooth loss, and are candidates for full arch implant-supported prosthesis rehabilitation, are invited to participate, provided they meet the necessary health requirements for surgery. Group 1: Patients who have total tooth loss or partial tooth loss but do not meet the following conditions: 1. Having at least 3 remaining teeth or roots with mobility no greater than grade 1, and 2. The remaining teeth are distributed with at least 1 tooth in the front and 1 tooth in the back on each side of the arch. These patients will have bone screws placed on the bone to serve as landmarks for implant placement using the dynamic navigation system. Group 2: Patients who have at least 3 remaining teeth, all with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side of the arch. These teeth will serve as landmarks for implant placement. Study Methodology: Group 1: Patients who have total or partial tooth loss, and do not meet the conditions of having at least 3 remaining teeth with mobility no greater than grade 1, and having at least one tooth in the front and one in the back on each side, will have bone screws placed on the bone as landmarks for implant placement. Group 2: Patients with at least 3 remaining teeth with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side, will use these teeth as landmarks for implant placement. After surgery, the implant deviation from the planned implant data will be evaluated to assess the accuracy of implant placement. Factors such as implant position deviation, surgery time, and complications will be evaluated to compare the effectiveness between the two groups. Benefits and Risks: 1. Benefits: 1. Improved accuracy in implant placement using the Dynamic Navigation System. 2. Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study. 3. Scientific contribution to improving implant placement methods for future patients. 2. Risks: 1. Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system. 2. Radiation exposure from imaging tests, particularly CBCT scans, will be required. The radiation exposure is minimal and within safe limits. 3. Slight increase in surgery time, typically 2-5 minutes longer than traditional surgery, for preparation and calibration of the navigation system to ensure its proper functionality. 4. For Group 1 participants, bone screws (4-6 screws) will be placed along the jaw arch where the implants are to be positioned.

Detailed description

Study Overview: Full arch implant surgery is a highly effective treatment for patients with total or partial tooth loss. However, determining the precise implant placement is key to ensuring long-term success. This study compares two methods for determining landmarks for implant placement: using bone-fixed screws (Group 1) versus using remaining teeth that need to be extracted (Group 2). Study Procedure: 1. Pre-surgery: Patients will undergo general health screenings and a CT scan to plan the surgery. 2. Surgery: Patients will be assigned to: 1. Group 1: Patients with fewer than 3 remaining teeth or teeth with mobility greater than grade 1, including at least one tooth in the front and one in the back on each side, will have bone screws placed on the bone as landmarks for implant placement using the dynamic navigation system. 2. Group 2: Patients with at least 3 remaining teeth, with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side, will use these teeth as landmarks for implant placement. Post-surgery Evaluation: After surgery, the implant deviation from the planned implant data will be assessed. This will measure the accuracy of the implant placement by comparing the actual position of the implants with the planned position. Benefits and Risks: 1. Benefits: 1. Improved accuracy in implant placement using the Dynamic Navigation System. 2. Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study. 3. Scientific contribution to improving implant placement methods for future patients. 2. Risks: 1. Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system. 2. Radiation exposure from imaging tests, particularly CBCT scans, will be required. Even if patients do not participate in this study, the CBCT scan is a standard part of the implant placement procedure, and the radiation exposure from CBCT is minimal and within safe limits. 3. Slight increase in surgery time, typically 2-5 minutes longer than traditional surgery, for preparation and calibration of the navigation system to ensure its proper functionality. 4. For Group 1 participants, bone screws (4-6 screws) will be placed along the jaw arch where the implants are to be positioned. These screws serve as reference points for the navigation system. Confidentiality: All patient information will be kept strictly confidential. Health data and study outcomes will only be used for research purposes and will not be shared with any third parties without the patient's consent.

Conditions

• Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation

Interventions

Type	Name	Description
DEVICE	Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks	This study uses a dynamic navigation system for implant placement in fully edentulous patients requiring full arch prosthesis rehabilitation. The system incorporates bone screws (placed as reference points on the jaw arch) to guide the accurate placement of implants. Unlike traditional freehand implant placement, this dynamic navigation system aims to minimize deviation from the planned implant positions while also reducing the time required for the surgical procedure. The results will be compared to a group where landmarks are based on remaining teeth to assess accuracy and time efficiency of the system.
DEVICE	Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks	In this arm, participants will undergo implant placement using a dynamic navigation system, where the reference points for implant positioning are based on the remaining teeth to be extracted. This approach, in contrast to the bone screw method used in Group 1, relies on the teeth that will be removed as landmarks to guide the accuracy of implant placement. The primary goal is to evaluate the accuracy of the implant placement and the time required for the procedure using this method. The results from this group will be compared to those from Group 1, where bone screws are placed as reference points, to assess the accuracy and time efficiency of both approaches.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2025-05-08
• Last updated: 2025-05-11

Locations

2 sites across 1 country: Vietnam

Regulatory

• FDA-regulated device study