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

Prosthesis User Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052501
• Other study ID #: DMarques
• Status: Not yet recruiting
• Start date: March 30, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: March 2024
• Source: Implantology Institute
• Contact: Duarte Marques, DDS, PhD
• Phone: +351 217 210 980
• Email: d.marques[@]institutoimplantologia.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lip
• Occlusion
• Oral Soft Tissue Conditions
• Prosthesis User

Intervention

Procedure:
• Removable of the full arch implant-supported prostheses
The intervention planned will be the removal of full arch implant-supported prostheses and the acquisition of a digital image through a facial scanner before and after this moment.

Locations

Country	Name	City	State
Portugal	Implantology Institute	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Implantology Institute

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Confounding factors	Type of definitive rehabilitation, time of implant surgery, extension of rehabilitation/edentulism	same day
Primary	Volumetric changes in peri-oral area	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	Distance between the upper lip and E-line in sagital profile	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
Secondary	Distance between the lower lip and E-line in sagital profile	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
Secondary	Naso-labial angle	The fourth outcome is to quantify the changes in the naso-labial angle related to the absence of the fixed prostheses	same day