Three-dimensional Assessment of Facial Alterations Induced by Dental Prostheses

Analysis of Three-dimensional Modifications Caused by Full Arch Implant Supported Dental Prosthesis With a Facial Scanner

Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper.

Study Overview

• Status: Completed
• Conditions: Soft Tissue
• Intervention / Treatment: Device: Facial scanner (Bellus3D) to assess perioral alterations

Detailed Description

3 dimensional evaluation of lip support by the use of full arch impplant supported rehabilitations with the use of a facial scannner. Determination of discrepacies between the obtained facial scan and conventional measurements made by a digital caliper on the face.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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:

• Patients rehabilitated with full implant supported upper dental prostheses.

Exclusion Criteria:

• Patients without beard, facial deformities, earrings or braces.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patient with or without dental prostheses; The patient will be submitted to two facial scans, one with and another without the dental prostheses and the obtained datasets will be compared to assess the differences. Marks will be made in the face to allow for measurements (digital and conventional)	Device: Facial scanner (Bellus3D) to assess perioral alterations; Use of a digital caliper for conventional measurements and a facial scanner (Bellus3D) to analyse the modifications induced by the use of implant supported dental prostheses in the lip support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue changes in µm with and without implant supported dental prostheses	Differences in the perioral soft tissues with and without dental prostheses in µm	Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses

Collaborators and Investigators

• Sponsor: Implantology Institute
• Collaborators: Grupo de Investigação em Bioquímica e Biologia Oral

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): June 20, 2020
• Study Completion (ACTUAL): June 21, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (ACTUAL): August 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Imaging, Three-Dimensional; accuracy; Technology, Dental; extra-oral scanner
• Other Study ID Numbers: II2019-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No