Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry

August 1, 2023 updated by: William Negreiros

The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard School of Dental Medicine

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

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intraoral Scanning
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.
Experimental: Photogrammetry Scanning
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
Time Frame: During procedure [two hours]
During procedure [two hours]

Collaborators and Investigators

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

Sponsor

William Negreiros

Collaborators

ITI International Team for Implantology, Switzerland

Investigators

  • Study Chair: German O Gallucci, DMD, Harvard School of Dental Medicine

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)

August 12, 2019

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

May 2, 2022

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-0660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans for IPD sharing because the study is complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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