NCT06963242

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

Recruiting now NA Last updated 11 May 2025

What this trial tests

NA trial testing Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks in Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation in 12 participants. Currently enrolling.

Timeline

1 July 2024

Primary endpoint
31 August 2025

31 December 2025

Quick facts

Lead sponsor	University of Medicine and Pharmacy at Ho Chi Minh City
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 July 2024
Primary completion	31 August 2025
Estimated completion	31 December 2025
Sites	2 locations across Vietnam

Drugs / interventions tested

• Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks
• Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks

Conditions studied

• Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation — all drugs for Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation →

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Who can join

18 and older, any sex, with Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.