Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis RehabilitationNCT06963242
Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis
A study testing Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks and Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks in people with Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation
- What is being tested?
- Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks and Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Dental Center
Ho Chi Minh City, 700000
Anh Thi Nguyet Nguyen, +8428 3855 9225, fos@ump.edu.vn
- Recruiting
Van Hanh General Hospital
Ho Chi Minh City, 700000
Phuong Thi Bich Le, +8428 3863 2553, fos@ump.edu.vn
About this study
Official title: Accuracy of Dynamic Navigation System in Implant Surgery for Full Arch Prosthesis
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
Read more
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:
- Having at least 3 remaining teeth or roots with mobility no greater than grade 1, and
- 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:
- Benefits:
- Improved accuracy in implant placement using the Dynamic Navigation System.
- Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study.
- Scientific contribution to improving implant placement methods for future patients.
- Risks:
- Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system.
- Radiation exposure from imaging tests, particularly CBCT scans, will be required. The radiation exposure is minimal and within safe limits.
- 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.
- For Group 1 participants, bone screws (4-6 screws) will be placed along the jaw arch where the implants are to be positioned.
Read the 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:
- Pre-surgery: Patients will undergo general health screenings and a CT scan to plan the surgery.
- Surgery: Patients will be assigned to:
- 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.
- 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:
- Benefits:
- Improved accuracy in implant placement using the Dynamic Navigation System.
- Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study.
- Scientific contribution to improving implant placement methods for future patients.
- Risks:
- Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system.
- 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.
- 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.
- 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
- Being tested
- Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks, Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Navigation System for Implant Placement Using Bone Screws as LandmarksDevice
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.
Dynamic Navigation System for Implant Placement Using Remaining Teeth as LandmarksDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone Screw Group (Group 1) | Experimental | In this arm, participants will undergo implant placement using a dynamic navigation system. Bone screws (4-6 screws) will be placed in the jaw arch as reference points to ensure accurate implant placement. The primary objectives are to measure the deviation in implant placement compared to the planned data and to assess the surgery time required for implant placement using this system. The results will be compared with those from Group 2, where landmarks are based on remaining teeth to be extracted, to evaluate the accuracy and time efficiency between the two approaches. Receives: Device: Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks |
| Tooth Landmark Group (Group 2) | Experimental | In this arm, participants will undergo implant placement using a dynamic navigation system. Landmarks based on remaining teeth to be extracted will be used as reference points to ensure accurate implant placement. The primary objectives are to measure the deviation in implant placement compared to the planned data and to assess the surgery time required for implant placement using this system. The results will be compared with those from Group 1, where bone screws were placed as landmarks, to evaluate the accuracy and time efficiency between the two approaches. Receives: Device: Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular Deviation
The primary outcome measure for this study is to evaluate the angular Deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Global Platform Deviation
The primary outcome measure for this study is to evaluate the global platform deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Global Apical Deviation
The primary outcome measure for this study is to evaluate the global apical deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Platform Depth Deviation
The primary outcome measure for this study is to evaluate the platform depth deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Apical Depth Deviation
The primary outcome measure for this study is to evaluate the apical depth deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Platform Bucco-lingual Deviation
The primary outcome measure for this study is to evaluate the platform bucco-lingual deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Platform Mesiodistal Deviation
The primary outcome measure for this study is to evaluate the platform mesiodistal deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Apical Bucco-lingual Deviation
The primary outcome measure for this study is to evaluate the apical bucco-lingual deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Apical Mesiodistal Deviation
The primary outcome measure for this study is to evaluate the apical mesiodistal deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Measured: The assessment of implant deviation will be measured immediately after surgery
Calibration Time
This outcome measure evaluates the calibration time required for the dynamic navigation system before implant placement, comparing Group 1 (bone screw landmarks) and Group 2 (remaining teeth as landmarks). Calibration time is measured from the moment the system is set up to the point where it is ready to guide implant placement. This time frame includes adjustments and validation of the system to ensure accurate implant positioning.
The primary goal is to compare the calibration times between the two groups to evaluate if the use of bone screws (Group 1) or remaining teeth (Group 2) as landmarks affects the calibration time required by the dynamic navigation system.
Measured: Calibration time will be recorded during the pre-surgical phase of the implant procedure, immediately before implant placement, in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jul 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis RehabilitationStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tran Cao Nhiem, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Nhiem Cao Tran, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963242
- Sponsor's protocol ID
- 24384-DHYD
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We intend to share IPD regarding the deviation in implant positioning from planned data and the calibration times recorded during the surgical procedures. No personally identifiable information (PII) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Dynamic Navigation System in Implant Surgery for Full Arch Prosthesis
- ClinicalTrials.gov ID
- NCT06963242
- Acronym / sponsor ID
- 24384-DHYD
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Having at least 3 remaining teeth or roots with mobility no greater than grade 1, and
- 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:
- Benefits:
- Improved accuracy in implant placement using the Dynamic Navigation System.
- Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study.
- Scientific contribution to improving implant placement methods for future patients.
- Risks:
- Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system.
- Radiation exposure from imaging tests, particularly CBCT scans, will be required. The radiation exposure is minimal and within safe limits.
- 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.
- 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:
- Pre-surgery: Patients will undergo general health screenings and a CT scan to plan the surgery.
- Surgery: Patients will be assigned to:
- 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.
- 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:
- Benefits:
- Improved accuracy in implant placement using the Dynamic Navigation System.
- Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study.
- Scientific contribution to improving implant placement methods for future patients.
- Risks:
- Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bone Screw Group (Group 1) | Experimental | Device: Dynamic Navigation System for Implant Placement Using Bone Screws as LandmarksIn this arm, participants will undergo implant placement using a dynamic navigation system. Bone screws (4-6 screws) will be placed in the jaw arch as reference points to ensure accurate implant placement. The primary objectives are to measure the deviation in implant placement compared to the planned data and to assess the surgery time required for implant placement using this system. The results will be compared with those from Group 2, where landmarks are based on remaining teeth to be extracted, to evaluate the accuracy and time efficiency between the two approaches. |
| Tooth Landmark Group (Group 2) | Experimental | Device: Dynamic Navigation System for Implant Placement Using Remaining Teeth as LandmarksIn this arm, participants will undergo implant placement using a dynamic navigation system. Landmarks based on remaining teeth to be extracted will be used as reference points to ensure accurate implant placement. The primary objectives are to measure the deviation in implant placement compared to the planned data and to assess the surgery time required for implant placement using this system. The results will be compared with those from Group 1, where bone screws were placed as landmarks, to evaluate the accuracy and time efficiency between the two approaches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Navigation System for Implant Placement Using Bone Screws as LandmarksThis 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 | Bone Screw Group (Group 1) |
| Dynamic Navigation System for Implant Placement Using Remaining Teeth as LandmarksIn 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. | Device | Tooth Landmark Group (Group 2) |
Primary outcome
Angular Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the angular Deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Global Platform Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the global platform deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Global Apical Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the global apical deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Platform Depth Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the platform depth deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Apical Depth Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the apical depth deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Platform Bucco-lingual Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the platform bucco-lingual deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Platform Mesiodistal Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the platform mesiodistal deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Apical Bucco-lingual Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the apical bucco-lingual deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Apical Mesiodistal Deviation
Time frame: The assessment of implant deviation will be measured immediately after surgery
The primary outcome measure for this study is to evaluate the apical mesiodistal deviation in implant placement when using the dynamic navigation system with bone screw landmarks (Group 1) versus remaining teeth landmarks (Group 2). Implant deviation is defined as the difference between the planned implant positions and the actual placement based on the navigation system. This outcome will help assess the precision of implant placement and compare the two groups for improved accuracy in full arch rehabilitation procedures.
Calibration Time
Time frame: Calibration time will be recorded during the pre-surgical phase of the implant procedure, immediately before implant placement, in both groups.
This outcome measure evaluates the calibration time required for the dynamic navigation system before implant placement, comparing Group 1 (bone screw landmarks) and Group 2 (remaining teeth as landmarks). Calibration time is measured from the moment the system is set up to the point where it is ready to guide implant placement. This time frame includes adjustments and validation of the system to ensure accurate implant positioning. The primary goal is to compare the calibration times between the two groups to evaluate if the use of bone screws (Group 1) or remaining teeth (Group 2) as landmarks affects the calibration time required by the dynamic navigation system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Yes. We intend to share IPD regarding the deviation in implant positioning from planned data and the calibration times recorded during the surgical procedures. No personally identifiable information (PII) will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nhiem Cao Tran principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Navigation System for Implant Placement Using Bone Screws as Landmarks and Dynamic Navigation System for Implant Placement Using Remaining Teeth as Landmarks in people with Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nhiem Cao Tran (+84936221609, tcnhiem.nt22@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular Deviation (time frame: The assessment of implant deviation will be measured immediately after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.