Comparison of Conventional Impressions, Intraoral Scanners and Digital Photogrammetry for Full-arch Implant Prosthesis.

NCT06570499 | Recruiting

• 1 other identifier: B7072024000032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to compare implant-supported definitive impressions in edentulous patients (mandible or maxilla) with 4 to 8 osseointegrated implants. The main questions it aims to answer are : The primary outcome of this prospective clinical comparative study is to analyse the precision of a complete-arch impression. The secondary aim is to obtain patient satisfaction with these new types of impression. The different impressions (conventional, intraoral scanner and photogrammetry) will be taken twice on the same patient.

Conditions

Dental Implant Failed

Keywords

accuracy, photogrammetry, dental implant

Outcome Measures

Primary Outcomes (1)

• Compare the precision of a complete-arch impression

  6 impressions are taken on one patient

  The impressions will be taken on the same day, the appointment lasts one hour.

Secondary Outcomes (1)

• Obtain patient satisfaction with these new types of impression.

  The questionnaire is handed out after the impressions, during the only appointment of this study (one hour).

Study Arms (1)

Patients with 4-8 osseointegrated implants

OTHER

On the patient, we will successively take 6 impressions (2 conventional, 2 intraoral scanner, 2 photogrammetry) and then analyze these impressions to measure the repeatability of a technique. After each type of impression, a satisfaction questionnaire in VAS format will be given to the patient.

Other: Implant impression

Interventions

Implant impression OTHER

definitive impressions on implants

Patients with 4-8 osseointegrated implants

Eligibility Criteria

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

You may qualify if:

• edentulous maxilla or mandible with 4 to 8 osseointegrated implants (NobelBiocare®) and transgingival abutments tightened to 35N/cm (Multi-unit, NobelBiocare®).

You may not qualify if:

• Patients with non-osseointegrated implants
• Patients with different implant systems
• Patients with incomplete edentulism

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (1)

Institut de Dentisterie

Liège, Liege, 4000, Belgium

RECRUITING

Study Officials

• Marc Pr Lamy, Phd

  Centre Hospitalier Universitaire de Liege

  STUDY DIRECTOR

Central Study Contacts

Nathalie Robert, DDS

CONTACT

+32496318211; n.robert@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Model Details: a group of patients: 6 different impressions taken from the same patient. Analysis of the impressions in a second step

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: June 18, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 15, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)