Dental Implantation AccuracyNCT07199153
Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial
A study testing D Printed Custom Registration Marker for Dynamic Navigation in people with Dental Implantation Accuracy, run by Sherif Aly Sadek at 1 site in Egypt.
Trial summary
This clinical trial evaluates the accuracy of a 3D printed custom-made registration method for dynamic navigation implant surgery using the Mininavident system in the esthetic zone of the anterior maxilla. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Implantation Accuracy
- What is being tested?
- D Printed Custom Registration Marker for Dynamic Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 15 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single missing tooth in the anterior maxilla
- ≥12 mm bone height and ≥5.5 mm width
- D3 bone density
- Angle's Class I occlusion
- No systemic contraindications to implant surgery
Who cannot join
- Heavy smoking or uncontrolled diabetes
- Radiation therapy involving the head and neck
- Parafunctional habits (e.g., bruxism)
- Class III malocclusion or edge-to-edge bites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Hala Soliman, +201006788228, hala.zakaria@dentistry.cu.edu.eg
Hala Soliman
About this study
This clinical trial evaluates the accuracy of a 3D printed custom-made registration method for dynamic navigation implant surgery using the Mininavident system in the esthetic zone of the anterior maxilla. Ten patients with a single missing anterior tooth will undergo CBCT-based planning, intraoral scanning, and guided implant placement using 3D printed registration markers. Postoperative CBCT analysis will measure deviations between planned and placed implants in terms of angular, coronal, and apical positions. The study aims to determine whether 3D printed markers provide clinically acceptable accuracy (<2 mm, <5°) and to assess their feasibility as a reproducible alternative to standard registration methods.
Read the detailed description
Accurate implant positioning is essential for esthetic and functional success, particularly in the anterior maxilla. Dynamic navigation systems (DNS) provide real-time guidance but depend on reliable registration between patient anatomy and virtual planning. Errors may occur with conventional fiducial markers, highlighting the need for more precise methods.
This clinical trial investigates the use of 3D printed custom registration markers with the Mininavident DNS for implant placement in the esthetic zone. Ten patients with a single missing anterior tooth will undergo CBCT-based planning and guided implant placement using the custom markers. Postoperative CBCT scans will be compared with preoperative plans to measure positional and angular deviations.
The primary outcome is the accuracy of implant placement, with deviations expected to remain within clinically acceptable limits (<2 mm, <5°). Secondary outcomes include assessing the feasibility and reproducibility of incorporating 3D printed registration into DNS workflows. Results may validate this approach as a cost-effective, patient-specific solution to enhance precision and predictability in implant dentistry.
- Conditions
- Dental Implantation Accuracy
- Being tested
- D Printed Custom Registration Marker for Dynamic Navigation
- Keywords
- Dynamic Navigation Surgery, Dental Implant Surgery, Implant Accuracy, Esthetic Zone, Computer-Guided Implantology, Digital Dentistry, Prosthetically Driven Implant Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D Printed Custom Registration Marker for Dynamic NavigationDevice
A patient-specific, 3D printed registration marker designed for use with the Mininavident dynamic navigation system. The marker is fabricated based on CBCT and intraoral scans, enabling accurate registration between virtual planning and clinical implant placement in the esthetic zone. Accuracy of placement is assessed through postoperative CBCT superimposition.
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed Registration for Dynamic Navigation Surgery | Experimental | Participants with a single missing anterior maxillary tooth will undergo implant placement using the Mininavident dynamic navigation system with a custom-made, 3D printed registration marker. The marker enables registration of CBCT and intraoral scans for prosthetically driven implant planning and real-time guided surgery. Receives: Device: D Printed Custom Registration Marker for Dynamic Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Implant Placement Using 3D Printed Registration Markers
Accuracy will be assessed by measuring deviations between the planned and actual implant positions using postoperative CBCT superimposed with the preoperative plan.
Measured: Within 1 week after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start10 Aug 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implantation AccuracyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherif Aly Sadek
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Sherif Aly Sadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199153
- Sponsor's protocol ID
- 22-4-24
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified, aggregate data (summary of implant deviation measurements and feasibility outcomes) will be shared. No individual participant-level raw data will be made available. Data may be provided upon reasonable request to the principal investigator for academic or scientific purposes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of 3D Printed Custom-Made Registration Method for Dynamic Navigation Implant Surgery Using Mininavident in the Esthetic Zone: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07199153
- Acronym / sponsor ID
- 22-4-24
- Conditions
- Dental Implantation Accuracy
- Keywords
- Dynamic Navigation Surgery, Dental Implant Surgery, Implant Accuracy, Esthetic Zone, Computer-Guided Implantology, Digital Dentistry, Prosthetically Driven Implant Planning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sherif Aly SadekUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 30 Sep 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.
This clinical trial evaluates the accuracy of a 3D printed custom-made registration method for dynamic navigation implant surgery using the Mininavident system in the esthetic zone of the anterior maxilla. Ten patients with a single missing anterior tooth will undergo CBCT-based planning, intraoral scanning, and guided implant placement using 3D printed registration markers. Postoperative CBCT analysis will measure deviations between planned and placed implants in terms of angular, coronal, and apical positions. The study aims to determine whether 3D printed markers provide clinically acceptable accuracy (<2 mm, <5°) and to assess their feasibility as a reproducible alternative to standard registration methods.
Detailed description
Accurate implant positioning is essential for esthetic and functional success, particularly in the anterior maxilla. Dynamic navigation systems (DNS) provide real-time guidance but depend on reliable registration between patient anatomy and virtual planning. Errors may occur with conventional fiducial markers, highlighting the need for more precise methods.
This clinical trial investigates the use of 3D printed custom registration markers with the Mininavident DNS for implant placement in the esthetic zone. Ten patients with a single missing anterior tooth will undergo CBCT-based planning and guided implant placement using the custom markers. Postoperative CBCT scans will be compared with preoperative plans to measure positional and angular deviations.
The primary outcome is the accuracy of implant placement, with deviations expected to remain within clinically acceptable limits (<2 mm, <5°). Secondary outcomes include assessing the feasibility and reproducibility of incorporating 3D printed registration into DNS workflows. Results may validate this approach as a cost-effective, patient-specific solution to enhance precision and predictability in implant dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Printed Registration for Dynamic Navigation Surgery | Experimental | Device: D Printed Custom Registration Marker for Dynamic NavigationParticipants with a single missing anterior maxillary tooth will undergo implant placement using the Mininavident dynamic navigation system with a custom-made, 3D printed registration marker. The marker enables registration of CBCT and intraoral scans for prosthetically driven implant planning and real-time guided surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Single missing tooth in the anterior maxilla
- ≥12 mm bone height and ≥5.5 mm width
- D3 bone density
- Angle's Class I occlusion
- No systemic contraindications to implant surgery
Key exclusion criteria (4 listed)
- Heavy smoking or uncontrolled diabetes
- Radiation therapy involving the head and neck
- Parafunctional habits (e.g., bruxism)
- Class III malocclusion or edge-to-edge bites
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 |
|---|---|---|
| D Printed Custom Registration Marker for Dynamic NavigationA patient-specific, 3D printed registration marker designed for use with the Mininavident dynamic navigation system. The marker is fabricated based on CBCT and intraoral scans, enabling accurate registration between virtual planning and clinical implant placement in the esthetic zone. Accuracy of placement is assessed through postoperative CBCT superimposition. | Device | 3D Printed Registration for Dynamic Navigation Surgery |
Primary outcome
Accuracy of Implant Placement Using 3D Printed Registration Markers
Time frame: Within 1 week after implant placement
Accuracy will be assessed by measuring deviations between the planned and actual implant positions using postoperative CBCT superimposed with the preoperative plan.
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 30 Sep 2025.
- Individual participant dataSharing planned: Yes. Only de-identified, aggregate data (summary of implant deviation measurements and feasibility outcomes) will be shared. No individual participant-level raw data will be made available. Data may be provided upon reasonable request to the principal investigator for academic or scientific purposes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D Printed Custom Registration Marker for Dynamic Navigation in people with Dental Implantation Accuracy, run by Sherif Aly Sadek 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 5 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 30 Sep 2025. 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?
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 Hala Soliman (+201006788228, hala.zakaria@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Implant Placement Using 3D Printed Registration Markers (time frame: Within 1 week after implant placement). 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 30 Sep 2025.