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NCT04753866 Clinical Trial

Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

Prosthesis User Clinical Trial

Official title:
Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04753866
Other study ID # II2020-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2021
Est. completion date September 1, 2021

Study information
Verified date February 2021
Source Implantology Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.

Description:

As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Indication for full arch implant rehabilitation Exclusion Criteria: - Presence of facial hair, braces, make up, earrings or any facial deformity

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Facial scanner
The Bellus3D facial scanner will be used to scan the patient before and after implant rehabilitation in order to produce .obj files that allow 3D comparisons and to obtain discrepancy values regarding lip support.

Locations
Country Name City State
Portugal Instituto de Implantologia Lisboa

Sponsors (1)
Lead Sponsor Collaborator
Implantology Institute

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lip Support Changes in 3D (µm) Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square) 1 month
Secondary Facial Alterations in 2D (mm) Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks 1 month
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