Clinical trial NCT06963242: Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis
Official title: Accuracy of Dynamic Navigation System in Implant Surgery for Full Arch Prosthesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation
Keywords: Dynamic Navigation
Implant placement surgery
Full arch prosthesis
Surgical guide
Implant rehabilitation
Fully edentulous
Computer-assisted surgery
Surgical navigation
Implant accuracy
Tooth-based landmark
Screw-based landmark
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel design study that compares two intervention groups. Group 1 uses bone screws (4-6 screws) as reference landmarks for dynamic navigation-guided implant placement, while Group 2 uses remaining teeth as reference landmarks. Both groups undergo the same surgical procedure, and the study evaluates the accuracy of implant placement with dynamic navigation. The interventions are carried out in parallel, and the results will be compared between the two groups to assess the effectiveness of each reference system in implant placement for full arch prosthesis rehabilitation.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who are fully edentulous or have partial edentulism and are in need of full arch prosthesis rehabilitation.
* Aged 18 years and older.
* Individuals in good general health (American Society of Anesthesiologists (ASA) class I or II)
* Willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Any serious medical (ASA class III or IV) or psychiatric conditions.
* Pregnant or breastfeeding women.
* General or Local Health Conditions Affecting Surgery: Systemic/local conditions that affect surgical healing, wound healing, and bone integration or use of medications such as steroids, bisphosphonates, or other drugs affecting bone health; smoking more than 10 cigarettes per day; acute infections at the planned implant site that have not been treated.
* Patients with a limited mouth opening of less than 40mm.

Primary outcomes:
measure: Angular Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Global Platform Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Global Apical Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Platform Depth Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Apical Depth Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Platform Bucco-lingual Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Platform Mesiodistal Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Apical Bucco-lingual Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Apical Mesiodistal Deviation
timeFrame: The assessment of implant deviation will be measured immediately after surgery
measure: Calibration Time
timeFrame: Calibration time will be recorded during the pre-surgical phase of the implant procedure, immediately before implant placement, in both groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Dental Center
city: Ho Chi Minh City
country: Vietnam
facility: Van Hanh General Hospital
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Nhiem Cao Tran
role: PRINCIPAL_INVESTIGATOR
References: