3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations

June 24, 2024 updated by: Implantology Institute

The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient.

The use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Digital technologies have evolved exponentially in the dental medicine field endorsing a change between the conventional methods to virtually based methodologies in daily clinical and laboratorial practice.

Combining facial aspects and proportions with dento-gingival parameters are the basis when planning a new smile design and a final rehabilitationFacial surface images can be used for more predictable measurement and quantification of vertical dimension of occlusion and lip support before, during and after a full mouth rehabilitation. Besides that, the information obtained by facial scanners have a major impact in treatment planning process especially in multidisciplinary complex cases with the simulation of the treatment, identification of patient's expectations and the implementation of an effective communication tool.

The 4D-virtual patient is the future regarding the management of a patient in dental medicine, since the beginning of the process with data acquisition for the diagnosis to the definitive oral rehabilitation procedures. Similar to any methodology, it is important to understand what are the basis of the facial scanning and what protocols can obtain better results in terms of accuracy and reliability.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population includes patients from private clinic in which the implant treatment was performed. These patients must have their maintenance appointments up to date.

Description

Inclusion Criteria:

  • Individuals with at least a full-arch implant supported rehabilitation in the upper arch
  • Individuals with a provisional or a definitive implant-supported prosthesis
  • Individuals with a stable occlusion function
  • Individuals with compliance to collaborate with the research protocol

Exclusion Criteria:

  • Individuals with history of hypersensitivity to external light or any similar condition
  • Individuals in an active surgical treatment period
  • Individuals in an active orthodontic treatment in the opposite arch
  • Individuals in an active facial treatment
  • Individuals who did not attend the maintenance visits

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric changes in peri-oral area
Time Frame: same day
The primary outcome is to evaluate the changes in volume in peri-oral area after removal a full arch implant-supported prostheses according to a digital analysis (RMS)
same day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance between the upper lip and E-line in sagital profile
Time Frame: same day
The secondary outcome is to quantify the changes in the distance between the upper lip and the Rickett's Aesthetic Line (E-line)
same day
Distance between the lower lip and E-line in sagital profile
Time Frame: same day
The third outcome is to quantify the changes in the distance between the lower lip and the Rickett's Aesthetic Line (E-line)
same day
Naso-labial angle
Time Frame: same day
The fourth outcome is to quantify the changes in the naso-labial angle related to the absence of the fixed prostheses
same day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confounding factors
Time Frame: same day
Type of definitive rehabilitation, time of implant surgery, extension of rehabilitation/edentulism
same day

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
  • Study Chair: Duarte Marques, DDS, PhD, Implantology Institute
  • Principal Investigator: Rita Alves, DDS, 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)

March 30, 2024

Primary Completion (Actual)

June 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DMarques

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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