Three-dimensional Assessment of Facial Alterations Induced by Dental Prostheses

NCT04050878 | Completed

• 1 other identifier: II2019-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Soft Tissue

Keywords

Imaging, Three-Dimensional; Technology, Dental; accuracy; extra-oral scanner

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient with or without dental prostheses

EXPERIMENTAL

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

Interventions

Facial scanner (Bellus3D) to assess perioral alterations DEVICE

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

Patient with or without dental prostheses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients rehabilitated with full implant supported upper dental prostheses.

You may not qualify if:

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

Sponsors & Collaborators

• Implantology Institute: lead
• Grupo de Investigação em Bioquímica e Biologia Oral: collaborator

Study Sites (1)

Instituto de Implantologia

Lisbon, 1070-064, Portugal

Location

Study Officials

• João Carames, 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
• Masking Details: Altough it is a single arm, the obtained STL files will be identified as A and B and the outcomes assessor will not be informed which group corresponds to the patient without or with the dental prostheses.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Determine the modifications caused by the use of different implant-supported dental prostheses in the soft tissues of the face, mainly upper and lower lips, by the use of a facial scanner.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: June 1, 2020
• Primary Completion: June 20, 2020
• Study Completion: June 21, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

PT (1)