Doctor EfficiencyFSTMPNCT06506747
Navigated Photogrammetry Compared to Standard Stereophotogrammetry
An observational study of Doctor Efficiency and Dental Prosthesis Fit, run by X-Nav Technologies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical outcome of Navigated Photogrammetry to standard stereophotogrammetry techniques in digital dentistry for the following two parameters: The amount of time needed to prepare the provisional digital files for use in the lab, measured in direct doctor interaction time. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Doctor Efficiency, Dental Prosthesis Fit
- What is being tested?
- Navigated Photogrammetry and Standard Photogrammetry
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2024to 23 May 2025
- Phase
- Observational
- 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
Study population: Study participants will be current patients of the investigators who are already intended to undergo implant placement surgery. Participants who willingly accepted the risks and benefits associated with placement of dental implants and stereophotogrammetry in the private practice of the investigators will be considered for inclusion in the study. Those patients deemed ineligible or who chose not to participate in the research study will be treated using conventional techniques.
Who may be able to join
- Adult patients requiring dental implant reconstruction who would undergo implant surgery with or without participation in the study.
- The patient must need at least four implants placed in one or both jaws of the maxilla or mandible.
- All patients must undergo informed consent and willingly read, understand, and accept the risks and benefits associated with the study.
- Willingness to participate for the duration of the study of at least six months follow-up
- Is healthy enough to undergo implant surgery. i.e. patient is classified by the American Society of Anesthesiology Scale (ASA) physical status classification status as ASA 1, 2 or 3.
- Ample bone to fully accommodate the implants without impinging on vital structures.
Who cannot join
- Patients who are not candidates for implant placement.
- Children and adolescents under 21 years of age.
- Refusal to sign informed consent.
- Less than four implants need to be restored.
- Severely immunocompromised patients
- Patients undergoing chemotherapy
Show all 13Show fewer
- Pregnant females.
- Classified by the ASA physical status classification status as ASA > 3,
- Patient at high risk for medication induced osteonecrosis of the jaw or any other medical condition that would preclude implant placement,
- Any systemic or local disease or condition that would compromise post healing and /or osseointegration.
- Need for systemic corticosteroids or any other medication that would compromise postoperative healing and / or osseointegration.
- Current alcohol or drug abuse.
- Inability or willingness to return for follow-up visits for the period of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Capital Center For Oral and Maxillofacial Surgery and For Cosmetic Surgery
Washington D.C., District of Columbia, 20037
About this study
Official title: Clinical Evaluation of FastMap Navigated Photogrammetry for Assessing Implant Positions Compared to Standard Stereophotogrammetry
The purpose of this study is to compare the clinical outcome of Navigated Photogrammetry to standard stereophotogrammetry techniques in digital dentistry for the following two parameters:
- The amount of time needed to prepare the provisional digital files for use in the lab, measured in direct doctor interaction time.
- Suitability of delivered provisional occlusion.
Participants will receive either a provisional manufactured by the output of Navigated Photogrammetry, or a provisional manufactured by the output of standard stereophotogrammetry.
Read the detailed description
Prior to implant surgery, a patient treatment plan is developed using a cone-beam computed tomography (CBCT), Intra Oral Scan (IOS), or digitized analog records. These records are loaded into a computer-aided design (CAD) program. The individual planning files are all related to one another in one coordinate system. This plan can be used to produce provisional restorations via computer-aided manufacturing (CAM). These files can also be used to implement the plan during surgery using either static guides or dynamic navigation.
Following implant surgery, the final placed implant locations will inherently have some deviation from the plan. It is important for the dentist to understand the physical location of the placed implants to achieve passive fit. In implant dentistry, a "passive fit" refers to the precise alignment and seating of prosthetic components onto dental implants without any internal stress or strain. Achieving a passive fit is crucial for the long-term success and stability of the dental prosthesis.
A potential method to obtain the final implant locations is stereophotogrammetry. Navigated Photogrammetry (NPG) is a new form of stereophotogrammetry which is inherently capable of relating the placed implants to the patient's anatomy using the registration of the Dynamic Surgical Navigation System (DSNS).
- Conditions
- Doctor Efficiency, Dental Prosthesis Fit
- Being tested
- Navigated Photogrammetry, Standard Photogrammetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated PhotogrammetryDevice
Navigated Photogrammetry shall be performed following implant surgery, rather than standard stereophotogrammetry. The patient will then receive a provisional that was manufactured using the data from FastMap Navigated Photogrammetry.
Standard PhotogrammetryDevice
The patient will receive the existing patient care protocol that includes anatomy information for the manufacturing of the provisional. Specifically, the patient will receive a preoperative IntraOral Scan (IOS) anatomy scan with IOS-compatible fiducials. Following implant surgery, the patient will receive a scan with a standard stereophotogrammetry device. Additionally, they will receive a post-op alignment IOS with IOS-compatible anatomy fiducials and IOS-compatible implant scan bodies. The patient will then receive a provisional that was manufactured using the data from the standard stereophotogrammetry device.
| Study group | Role | What they receive |
|---|---|---|
| FastMap Navigated Photogrammetry | Following implant surgery, the patient will then receive a provisional that was manufactured using the data from FastMap Navigated Photogrammetry. Receives: Device: Navigated Photogrammetry | |
| Standard Stereophotogrammetry | Following implant surgery, the patient will then receive a provisional that was manufactured using the data from Standard Stereophotogrammetry. Receives: Device: Standard Photogrammetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provisional prosthesis fit
The passive fit of the provisional prosthesis onto the implants as well as occlusal fit with the opposing jaw.
Measured: at provisional placement completion, approximately 2 weeks
Clinician interaction time
The amount of time needed to prepare each type of provisional digital files for use in the lab, measured in direct doctor interaction time.
Measured: at provisional placement completion, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start20 Jul 2024
- Primary completion25 Apr 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Doctor EfficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- X-Nav Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506747
- Sponsor's protocol ID
- DOC-002105
- Acronym
- FSTMP
- Status last verified
- May 2025
- First submitted
- 2 Jul 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pozzi A, Agliardi E, Lio F, Nagy K, Nardi A, Arcuri L. Accuracy of intraoral optical scan versus stereophotogrammetry for complete-arch digital implant impression: An in vitro study. J Prosthodont Res. 2024 Jan 16;68(1):172-180. doi: 10.2186/jpr.JPR_D_22_00251. Epub 2023 Aug 11.
PubMed 37574278Orejas-Perez J, Gimenez-Gonzalez B, Ortiz-Collado I, Thuissard IJ, Santamaria-Laorden A. In Vivo Complete-Arch Implant Digital Impressions: Comparison of the Precision of Three Optical Impression Systems. Int J Environ Res Public Health. 2022 Apr 3;19(7):4300. doi: 10.3390/ijerph19074300.
PubMed 35409985Revilla-Leon M, Att W, Ozcan M, Rubenstein J. Comparison of conventional, photogrammetry, and intraoral scanning accuracy of complete-arch implant impression procedures evaluated with a coordinate measuring machine. J Prosthet Dent. 2021 Mar;125(3):470-478. doi: 10.1016/j.prosdent.2020.03.005. Epub 2020 May 6.
PubMed 32386912Revilla-Leon M, Rubenstein J, Methani MM, Piedra-Cascon W, Ozcan M, Att W. Trueness and precision of complete-arch photogrammetry implant scanning assessed with a coordinate-measuring machine. J Prosthet Dent. 2023 Jan;129(1):160-165. doi: 10.1016/j.prosdent.2021.05.019. Epub 2021 Jun 18.
PubMed 34154820Tohme H, Lawand G, Chmielewska M, Makhzoume J. Comparison between stereophotogrammetric, digital, and conventional impression techniques in implant-supported fixed complete arch prostheses: An in vitro study. J Prosthet Dent. 2023 Feb;129(2):354-362. doi: 10.1016/j.prosdent.2021.05.006. Epub 2021 Jun 8.
PubMed 34112521Manzella C, Bignardi C, Burello V, Carossa S, Schierano G. Method to improve passive fit of frameworks on implant-supported prostheses: An in vitro study. J Prosthet Dent. 2016 Jul;116(1):52-8. doi: 10.1016/j.prosdent.2016.01.006. Epub 2016 Mar 2.
PubMed 26944406Jemt T, Hjalmarsson L. In vitro measurements of precision of fit of implant-supported frameworks. A comparison between "virtual" and "physical" assessments of fit using two different techniques of measurements. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e175-82. doi: 10.1111/j.1708-8208.2011.00416.x. Epub 2011 Dec 15.
PubMed 22171700Schwarz MS. Mechanical complications of dental implants. Clin Oral Implants Res. 2000;11 Suppl 1:156-8. doi: 10.1034/j.1600-0501.2000.011s1156.x.
PubMed 11168264
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of FastMap Navigated Photogrammetry for Assessing Implant Positions Compared to Standard Stereophotogrammetry
- ClinicalTrials.gov ID
- NCT06506747
- Acronym / sponsor ID
- FSTMP / DOC-002105
- Conditions
- Doctor Efficiency, Dental Prosthesis Fit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- X-Nav Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 17 Jul 2024 (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.
The purpose of this study is to compare the clinical outcome of Navigated Photogrammetry to standard stereophotogrammetry techniques in digital dentistry for the following two parameters:
- The amount of time needed to prepare the provisional digital files for use in the lab, measured in direct doctor interaction time.
- Suitability of delivered provisional occlusion.
Participants will receive either a provisional manufactured by the output of Navigated Photogrammetry, or a provisional manufactured by the output of standard stereophotogrammetry.
Detailed description
Prior to implant surgery, a patient treatment plan is developed using a cone-beam computed tomography (CBCT), Intra Oral Scan (IOS), or digitized analog records. These records are loaded into a computer-aided design (CAD) program. The individual planning files are all related to one another in one coordinate system. This plan can be used to produce provisional restorations via computer-aided manufacturing (CAM). These files can also be used to implement the plan during surgery using either static guides or dynamic navigation.
Following implant surgery, the final placed implant locations will inherently have some deviation from the plan. It is important for the dentist to understand the physical location of the placed implants to achieve passive fit. In implant dentistry, a "passive fit" refers to the precise alignment and seating of prosthetic components onto dental implants without any internal stress or strain. Achieving a passive fit is crucial for the long-term success and stability of the dental prosthesis.
A potential method to obtain the final implant locations is stereophotogrammetry. Navigated Photogrammetry (NPG) is a new form of stereophotogrammetry which is inherently capable of relating the placed implants to the patient's anatomy using the registration of the Dynamic Surgical Navigation System (DSNS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FastMap Navigated Photogrammetry | – | Device: Navigated PhotogrammetryFollowing implant surgery, the patient will then receive a provisional that was manufactured using the data from FastMap Navigated Photogrammetry. |
| Standard Stereophotogrammetry | – | Device: Standard PhotogrammetryFollowing implant surgery, the patient will then receive a provisional that was manufactured using the data from Standard Stereophotogrammetry. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be current patients of the investigators who are already intended to undergo implant placement surgery. Participants who willingly accepted the risks and benefits associated with placement of dental implants and stereophotogrammetry in the private practice of the investigators will be considered for inclusion in the study. Those patients deemed ineligible or who chose not to participate in the research study will be treated using conventional techniques.
Key inclusion criteria (6 listed)
- Adult patients requiring dental implant reconstruction who would undergo implant surgery with or without participation in the study.
- The patient must need at least four implants placed in one or both jaws of the maxilla or mandible.
- All patients must undergo informed consent and willingly read, understand, and accept the risks and benefits associated with the study.
- Willingness to participate for the duration of the study of at least six months follow-up
- Is healthy enough to undergo implant surgery. i.e. patient is classified by the American Society of Anesthesiology Scale (ASA) physical status classification status as ASA 1, 2 or 3.
Key exclusion criteria (13 listed)
- Patients who are not candidates for implant placement.
- Children and adolescents under 21 years of age.
- Refusal to sign informed consent.
- Less than four implants need to be restored.
- Severely immunocompromised patients
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 |
|---|---|---|
| Navigated PhotogrammetryNavigated Photogrammetry shall be performed following implant surgery, rather than standard stereophotogrammetry. The patient will then receive a provisional that was manufactured using the data from FastMap Navigated Photogrammetry. | Device | FastMap Navigated Photogrammetry |
| Standard PhotogrammetryThe patient will receive the existing patient care protocol that includes anatomy information for the manufacturing of the provisional. Specifically, the patient will receive a preoperative IntraOral Scan (IOS) anatomy scan with IOS-compatible fiducials. Following implant surgery, the patient will receive a scan with a standard stereophotogrammetry device. Additionally, they will receive a post-op alignment IOS with IOS-compatible anatomy fiducials and IOS-compatible implant scan bodies. The patient will then receive a provisional that was manufactured using the data from the standard stereophotogrammetry device. | Device | Standard Stereophotogrammetry |
Primary outcome
Provisional prosthesis fit
Time frame: at provisional placement completion, approximately 2 weeks
The passive fit of the provisional prosthesis onto the implants as well as occlusal fit with the opposing jaw.
Clinician interaction time
Time frame: at provisional placement completion, approximately 2 weeks
The amount of time needed to prepare each type of provisional digital files for use in the lab, measured in direct doctor interaction time.
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 4 Jun 2025.
- Background: PubMed 37574278Pozzi A, Agliardi E, Lio F, Nagy K, Nardi A, Arcuri L. Accuracy of intraoral optical scan versus stereophotogrammetry for complete-arch digital implant impression: An in vitro study. J Prosthodont Res. 2024 Jan 16;68(1):172-180. doi: 10.2186/jpr.JPR_D_22_00251. Epub 2023 Aug 11.
- Background: PubMed 35409985Orejas-Perez J, Gimenez-Gonzalez B, Ortiz-Collado I, Thuissard IJ, Santamaria-Laorden A. In Vivo Complete-Arch Implant Digital Impressions: Comparison of the Precision of Three Optical Impression Systems. Int J Environ Res Public Health. 2022 Apr 3;19(7):4300. doi: 10.3390/ijerph19074300.
- Background: PubMed 32386912Revilla-Leon M, Att W, Ozcan M, Rubenstein J. Comparison of conventional, photogrammetry, and intraoral scanning accuracy of complete-arch implant impression procedures evaluated with a coordinate measuring machine. J Prosthet Dent. 2021 Mar;125(3):470-478. doi: 10.1016/j.prosdent.2020.03.005. Epub 2020 May 6.
- Background: PubMed 34154820Revilla-Leon M, Rubenstein J, Methani MM, Piedra-Cascon W, Ozcan M, Att W. Trueness and precision of complete-arch photogrammetry implant scanning assessed with a coordinate-measuring machine. J Prosthet Dent. 2023 Jan;129(1):160-165. doi: 10.1016/j.prosdent.2021.05.019. Epub 2021 Jun 18.
- Background: PubMed 34112521Tohme H, Lawand G, Chmielewska M, Makhzoume J. Comparison between stereophotogrammetric, digital, and conventional impression techniques in implant-supported fixed complete arch prostheses: An in vitro study. J Prosthet Dent. 2023 Feb;129(2):354-362. doi: 10.1016/j.prosdent.2021.05.006. Epub 2021 Jun 8.
- Background: PubMed 26944406Manzella C, Bignardi C, Burello V, Carossa S, Schierano G. Method to improve passive fit of frameworks on implant-supported prostheses: An in vitro study. J Prosthet Dent. 2016 Jul;116(1):52-8. doi: 10.1016/j.prosdent.2016.01.006. Epub 2016 Mar 2.
- Background: PubMed 22171700Jemt T, Hjalmarsson L. In vitro measurements of precision of fit of implant-supported frameworks. A comparison between "virtual" and "physical" assessments of fit using two different techniques of measurements. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e175-82. doi: 10.1111/j.1708-8208.2011.00416.x. Epub 2011 Dec 15.
- Background: PubMed 11168264Schwarz MS. Mechanical complications of dental implants. Clin Oral Implants Res. 2000;11 Suppl 1:156-8. doi: 10.1034/j.1600-0501.2000.011s1156.x.
- Individual participant dataSharing planned: No
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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. 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?
An observational study of Doctor Efficiency and Dental Prosthesis Fit, run by X-Nav Technologies, LLC at 1 site in United States.
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 6 inclusion and 13 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 4 Jun 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 United States. 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?
Provisional prosthesis fit (time frame: at provisional placement completion, approximately 2 weeks). 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?
On the ClinicalTrials.gov record for NCT06506747, which also lists 8 linked publications.
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 4 Jun 2025.