Remaining RootNCT07380360
An Immediate Implant Will be Placed Using the MiniNaviDent System and Static Guide. A Postoperative CBCT Scan Will Then be Acquired and Superimposed Onto the Preoperative CBCT Scan to Assess and Compare Implant Deviation Relative to the Preoperative Plan
A study testing Dynamic navigation system-assisted dental implant placement and CAD/CAM static surgical guide-assisted dental implant placement in people with Remaining Root and Tooth Extraction, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical study aims to evaluate implant deviation during immediate implant placement using dynamic navigation. By utilizing implant planning software, two CBCT scans (preoperative and postoperative) will be superimposed to assess the accuracy of dynamic navigation in immediate implant placement, which is… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Remaining Root, Tooth Extraction
- What is being tested?
- Dynamic navigation system-assisted dental implant placement and CAD/CAM static surgical guide-assisted dental implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients at least 21 years old.
- Systemically healthy patients with no effect on the surgery.
- At least one hopeless maxillary or mandibular tooth to be restored using an implant.
- At least six residual teeth in the affected jaw.
Who cannot join
- A medical condition or medication that would impair bone healing.
- Poor oral hygiene
- Alcohol users.
- Smoking more than 10 cigarettes per day.
- History of head and neck radiotherapy.
- Pregnant females.
- Uncontrolled hypertensive or diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immediate Implant Placement Accuracy Using a Dynamic Navigation System. "Randomized Clinical Trial"
This clinical study aims to evaluate implant deviation during immediate implant placement using dynamic navigation. By utilizing implant planning software, two CBCT scans (preoperative and postoperative) will be superimposed to assess the accuracy of dynamic navigation in immediate implant placement, which is considered a more complex procedure compared to delayed implant placement
Read the detailed description
First, a fiducial marker will be placed in the patient's mouth, followed by a CBCT scan with the marker in position. The implant will then be virtually planned using implant planning software. Using the MiniNaviDent system and the fiducial marker, the implant will be placed. After placement, a postoperative CBCT scan will be obtained. The postoperative scan will be superimposed onto the preoperative scan to measure implant deviation.
- Conditions
- Remaining Root, Tooth Extraction
- Being tested
- Dynamic navigation system-assisted dental implant placement, CAD/CAM static surgical guide-assisted dental implant placement
- Keywords
- immediate implant, dynamic navigation, static guide, CBCT superimposition, guided implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic navigation system-assisted dental implant placementDevice
Dental implant placement performed using a dynamic computer-assisted navigation system with real-time guidance. The implant position is planned pre-operatively using CBCT (and intraoral scan data if applicable). During surgery, the system tracks the patient reference and the drill/handpiece and displays real-time guidance to follow the planned implant trajectory for osteotomy preparation and implant insertion.
Device name: mini Navident
CAD/CAM static surgical guide-assisted dental implant placementDevice
Dental implant placement performed using a patient-specific CAD/CAM static surgical guide. The guide is designed from the digital implant plan (CBCT and, if applicable, intraoral scan) and fabricated (e.g., 3D printed). The static guide (with sleeves) is used to guide osteotomy preparation and implant insertion according to the planned implant position.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic navigation-guided implant placement | Experimental | Dental implant osteotomy preparation and implant insertion performed using a dynamic navigation system to guide implant placement in real time according to the digital plan (CBCT-based planning with intraoperative navigation guidance) Receives: Device: Dynamic navigation system-assisted dental implant placement |
| Static guided implant placement | Active comparator | Implant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan. Receives: Device: CAD/CAM static surgical guide-assisted dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronal deviation (mm) Apical deviation (mm)
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in millimeters (mm)
Measured: Pre-op CBCT and post-op CBCT within 7 days after surgery
Angular deviation (degrees)
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in and the angular deviation in degrees was measured.
Measured: Pre-op CBCT and post-op CBCT within 7 days after surgery
Secondary outcomes (1)
Total surgical time (minutes)
Total operative time recorded in minutes from first mucosal incision to completion of final implant insertion (last implant fully seated). Time will be recorded by an independent observer using a stopwatch and compared between the dynamic navigation and Static Guide groups
Measured: Intraoperative (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start24 Nov 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remaining RootStudies of the same condition, open and under way.
- 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
- All participants will receive immediately placed implants following extraction
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380360
- Sponsor's protocol ID
- FDASU-RecIM012333
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediate Implant Placement Accuracy Using a Dynamic Navigation System. "Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07380360
- Acronym / sponsor ID
- FDASU-RecIM012333
- Conditions
- Remaining Root, Tooth Extraction
- Keywords
- immediate implant, dynamic navigation, static guide, CBCT superimposition, guided implant surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 2 Feb 2026 (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.
This clinical study aims to evaluate implant deviation during immediate implant placement using dynamic navigation. By utilizing implant planning software, two CBCT scans (preoperative and postoperative) will be superimposed to assess the accuracy of dynamic navigation in immediate implant placement, which is considered a more complex procedure compared to delayed implant placement
Detailed description
First, a fiducial marker will be placed in the patient's mouth, followed by a CBCT scan with the marker in position. The implant will then be virtually planned using implant planning software. Using the MiniNaviDent system and the fiducial marker, the implant will be placed. After placement, a postoperative CBCT scan will be obtained. The postoperative scan will be superimposed onto the preoperative scan to measure implant deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive immediately placed implants following extraction
| Arm | Type | Receives |
|---|---|---|
| Dynamic navigation-guided implant placement | Experimental | Device: Dynamic navigation system-assisted dental implant placementDental implant osteotomy preparation and implant insertion performed using a dynamic navigation system to guide implant placement in real time according to the digital plan (CBCT-based planning with intraoperative navigation guidance) |
| Static guided implant placement | Active comparator | Device: CAD/CAM static surgical guide-assisted dental implant placementImplant placement performed using a patient-specific CAD/CAM static surgical guide fabricated from the digital plan. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy patients at least 21 years old.
- Systemically healthy patients with no effect on the surgery.
- At least one hopeless maxillary or mandibular tooth to be restored using an implant.
- At least six residual teeth in the affected jaw.
Key exclusion criteria (7 listed)
- A medical condition or medication that would impair bone healing.
- Poor oral hygiene
- Alcohol users.
- Smoking more than 10 cigarettes per day.
- History of head and neck radiotherapy.
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-assisted dental implant placementDental implant placement performed using a dynamic computer-assisted navigation system with real-time guidance. The implant position is planned pre-operatively using CBCT (and intraoral scan data if applicable). During surgery, the system tracks the patient reference and the drill/handpiece and displays real-time guidance to follow the planned implant trajectory for osteotomy preparation and implant insertion. Device name: mini Navident | Device | Dynamic navigation-guided implant placement |
| CAD/CAM static surgical guide-assisted dental implant placementDental implant placement performed using a patient-specific CAD/CAM static surgical guide. The guide is designed from the digital implant plan (CBCT and, if applicable, intraoral scan) and fabricated (e.g., 3D printed). The static guide (with sleeves) is used to guide osteotomy preparation and implant insertion according to the planned implant position. | Device | Static guided implant placement |
Primary outcome
Coronal deviation (mm) Apical deviation (mm)
Time frame: Pre-op CBCT and post-op CBCT within 7 days after surgery
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in millimeters (mm)
Angular deviation (degrees)
Time frame: Pre-op CBCT and post-op CBCT within 7 days after surgery
Implant deviation was defined as the discrepancy between the planned implant position (as established in the preoperative planning software) and the actual implant position placed using dynamic navigation and a static surgical guide. To quantify this deviation, the postoperative CBCT was superimposed (registered) onto the preoperative planned CBCT, and the resulting spatial differences between the planned and placed implants were measured and reported in and the angular deviation in degrees was measured.
1 secondary outcome
Total surgical time (minutes)
Time frame: Intraoperative (day of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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-assisted dental implant placement and CAD/CAM static surgical guide-assisted dental implant placement in people with Remaining Root and Tooth Extraction, run by Ain Shams University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronal deviation (mm) Apical deviation (mm) (time frame: Pre-op CBCT and post-op CBCT within 7 days after surgery). The study lists 2 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 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.