Clinical trial NCT06052501: 3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
Official title: 3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Digital Technology
Prosthesis User
Lip
Oral Soft Tissue Conditions
Occlusion
Keywords: three-dimensional imaging
prosthodontics
full-arch
facial scanner
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volumetric changes in peri-oral area
timeFrame: same day
Secondary outcomes:
measure: Distance between the upper lip and E-line in sagital profile
timeFrame: same day
measure: Distance between the lower lip and E-line in sagital profile
timeFrame: same day
measure: Naso-labial angle
timeFrame: same day
Other outcomes:
measure: Confounding factors
timeFrame: same day
Locations:
city: Lisbon
country: Portugal
facility: Implantology Institute
Study officials:
affiliation: Implantology Institute
name: João Caramês, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Duarte Marques, DDS, PhD
role: STUDY_CHAIR
affiliation: Implantology Institute
name: Rita Alves, DDS
role: PRINCIPAL_INVESTIGATOR
References: