Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry
Primary Purpose
Edentulous Jaw
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital scanning
Photogrammetry
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw focused on measuring edentulous/edentulism, CAD-CAM, implantology, prosthetic dentistry, clinical studies/trial, clinical outcomes
Eligibility Criteria
Inclusion Criteria: Present with a completely edentulous arch with at least four implants Have bone-level implants Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis. Exclusion Criteria: Patients unable to tolerate the digital scans impressions Presented with implants other than bone-level platforms Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis Not completely edentulous.
Sites / Locations
- Harvard School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intraoral Scanning
Photogrammetry Scanning
Arm Description
Outcomes
Primary Outcome Measures
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
Secondary Outcome Measures
Full Information
NCT ID
NCT05972148
First Posted
July 25, 2023
Last Updated
August 1, 2023
Sponsor
William Negreiros
Collaborators
ITI International Team for Implantology, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT05972148
Brief Title
Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry
Official Title
The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
May 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Negreiros
Collaborators
ITI International Team for Implantology, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans.
The main question[s] it aims to answer are:
Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans?
Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?
Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment.
Scanbodies were screwed into their implants for the duration of the appointment.
They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry.
Intraoral and extraoral photography were taken.
At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted.
The procedures were not painful or required any form of local anesthetic
Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
Keywords
edentulous/edentulism, CAD-CAM, implantology, prosthetic dentistry, clinical studies/trial, clinical outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoral Scanning
Arm Type
Active Comparator
Arm Title
Photogrammetry Scanning
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Digital scanning
Intervention Description
Five intraoral scans, one for each arch before the insertion of scanbodies, were obtained. The implant locations were then marked, and the software trimmed a 6mm diameter circular section of the scan from the implant locations to allow the scanbodies to be added. Abutment-level polyetheretherketone (PEEK) scanbodies were hand-tightened onto each implant and not moved for the remainder of the scans. Scanbodies were scanned using a circular scan path, and scanning was finalized.
Intervention Type
Other
Intervention Name(s)
Photogrammetry
Intervention Description
Rectangular-shaped titanium photogrammetry scanbodies were hand-tightened onto the Implants. Scanbodies were not moved before completing all scans for each arch. A total of five scans of each arch were obtained using a photogrammetry device. Measurements were successfully recorded by turning them green on the computer screen.
Primary Outcome Measure Information:
Title
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
Time Frame
During procedure [two hours]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Present with a completely edentulous arch with at least four implants
Have bone-level implants
Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis.
Exclusion Criteria:
Patients unable to tolerate the digital scans impressions
Presented with implants other than bone-level platforms
Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis
Not completely edentulous.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
German O Gallucci, DMD
Organizational Affiliation
Harvard School of Dental Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Harvard School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans for IPD sharing because the study is complete.
Learn more about this trial
Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry
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