Navigated Photogrammetry Compared to Standard Stereophotogrammetry (FSTMP)

May 28, 2025 updated by: X-Nav Technologies, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Capital Center For Oral and Maxillofacial Surgery and For Cosmetic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FastMap Navigated Photogrammetry
Following implant surgery, the patient will then receive a provisional that was manufactured using the data from FastMap Navigated Photogrammetry.
Device: Navigated Photogrammetry
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 Stereophotogrammetry
Following implant surgery, the patient will then receive a provisional that was manufactured using the data from Standard Stereophotogrammetry.
Device: Standard Photogrammetry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at provisional placement completion, approximately 2 weeks
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.
at provisional placement completion, approximately 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

X-Nav Technologies, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2024

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

May 23, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • DOC-002105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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