NCT04753866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 12, 2021

Last Update Submit

September 8, 2021

Conditions

LipProsthesis UserSoft Tissue

Keywords

Dental EstheticsDental ImplantsThree-Dimensional ImagingOral Surgery

Outcome Measures

Primary Outcomes (1)

  • Lip Support Changes in 3D (μm)

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

    1 month

Secondary Outcomes (1)

  • Facial Alterations in 2D (mm)

    1 month

Study Arms (1)

Rehabilitated

EXPERIMENTAL

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

Facial scannerDEVICE

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.

Rehabilitated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for full arch implant rehabilitation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Implantologia

Lisbon, 1070-064, Portugal

Location

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia

Study Officials

  • João Caramês, DDS PhD

    Implantology Institute

    STUDY DIRECTOR

  • Duarte Marques, DDS PhD

    Implantology Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 15, 2021

Study Start

June 20, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)