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

NCT05972148 | Completed

• 1 other identifier: IRB18-0660
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Jaw

Keywords

edentulous/edentulism; CAD-CAM; implantology; prosthetic dentistry; clinical studies/trial; clinical outcomes

Outcome Measures

Primary Outcomes (1)

• To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions

  During procedure [two hours]

Study Arms (2)

Intraoral Scanning

ACTIVE COMPARATOR

Other: Digital scanning

Photogrammetry Scanning

EXPERIMENTAL

Other: Photogrammetry

Interventions

Digital scanning OTHER

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.

Intraoral Scanning

Photogrammetry OTHER

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.

Photogrammetry Scanning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Negreiros: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Study Officials

• German O Gallucci, DMD

  Harvard School of Dental Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: August 12, 2019
• Primary Completion: September 20, 2020
• Study Completion: May 2, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)