Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

Sponsor

Implantology Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04753866

Collaborator

(none)

Enrollment

Location

Arm

2.4

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lip Prosthesis User Soft Tissue	Device: Facial scanner	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations

Actual Study Start Date :

Jun 20, 2021

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Lip Support Changes in 3D (μm) [1 month]
Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)

Secondary Outcome Measures

Facial Alterations in 2D (mm) [1 month]
Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Indication for full arch implant rehabilitation

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Implantologia	Lisboa		Portugal	1070-064

Sponsors and Collaborators

Implantology Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Implantology Institute

ClinicalTrials.gov Identifier:

NCT04753866

Other Study ID Numbers:

II2020-06

First Posted:

Feb 15, 2021

Last Update Posted:

Sep 16, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Implantology Institute

Dental Esthetics

Dental Implants

Three-Dimensional Imaging

Oral Surgery

Study Results

No Results Posted as of Sep 16, 2021