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CompletedNCT04753866Updated Sep 16, 2021

Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

An interventional study of Facial scanner in Lip, Prosthesis User and Soft Tissue, sponsored by Implantology Institute. Completed at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Implantology Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Lip
  • Prosthesis User
  • Soft Tissue

Keywords

  • Dental Esthetics
  • Dental Implants
  • Three-Dimensional Imaging
  • Oral Surgery
03

In context

Lead sponsor

Implantology Institute is the lead sponsor of 17 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Indication for full arch implant rehabilitation

Exclusion criteria

Exclusion Criteria:

  • Presence of facial hair, braces, make up, earrings or any facial deformity
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Rehabilitated

    Initial lip support condition of the patient when presents himself/herself at the office with indication for full arch implant rehabilitation. Then, the patient is facially scanned before and after the implant surgery.

    Device: Facial scanner

Interventions

  • DeviceFacial 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.

06

What researchers measure

Primary outcomes

  1. Lip Support Changes in 3D (μm)

    Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)

    Time frame: 1 month

Secondary outcomes

  1. Facial Alterations in 2D (mm)

    Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks

    Time frame: 1 month

07

Study locations

1 site
  • Instituto de Implantologia
    Lisboa, 1070-064, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04753866
Lead sponsor
Implantology Institute
Responsible party
Sponsor
First posted
Feb 15, 2021
Start date
Jun 20, 2021
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Sep 16, 2021

Study contacts

João Caramês, DDS PhD
study director · Implantology Institute
Duarte Marques, DDS PhD
principal investigator · Implantology Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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