Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

September 8, 2021 updated by: Implantology Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Portugal
      • Lisboa, Portugal, 1070-064
        • Instituto de Implantologia

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for full arch implant rehabilitation

Exclusion Criteria:

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lip Support Changes in 3D (μm)
Time Frame: 1 month
Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial Alterations in 2D (mm)
Time Frame: 1 month
Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks
1 month

Collaborators and Investigators

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

Sponsor

Implantology Institute

Investigators

  • Study Director: João Caramês, DDS PhD, Implantology Institute
  • Principal Investigator: Duarte Marques, DDS PhD, Implantology Institute

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)

June 20, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • II2020-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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