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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2023
Source Harvard School of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Digital scanning
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.
Photogrammetry
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.

Locations

Country Name City State
United States Harvard School of Dental Medicine Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
William Negreiros ITI International Team for Implantology, Switzerland

Country where clinical trial is conducted

United States, 

Outcome

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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