Clinical trial NCT06506747: Navigated Photogrammetry Compared to Standard Stereophotogrammetry
Official title: Clinical Evaluation of FastMap Navigated Photogrammetry for Assessing Implant Positions Compared to Standard Stereophotogrammetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Doctor Efficiency
Dental Prosthesis Fit
Lead sponsor: X-Nav Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.
* 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Provisional prosthesis fit
timeFrame: at provisional placement completion, approximately 2 weeks
measure: Clinician interaction time
timeFrame: at provisional placement completion, approximately 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Capital Center For Oral and Maxillofacial Surgery and For Cosmetic Surgery
state: District of Columbia
Study officials:
References:
citation: 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.
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