Edentulous Jaw Clinical Trial
Official title:
The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks
NCT number | NCT05972148 |
Other study ID # | IRB18-0660 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 12, 2019 |
Est. completion date | May 2, 2022 |
Verified date | August 2023 |
Source | Harvard School of Dental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 2, 2022 |
Est. primary completion date | September 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Harvard School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
William Negreiros | ITI International Team for Implantology, Switzerland |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions | During procedure [two hours] |
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