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

NCT06052501 | Recruiting

• 1 other identifier: DMarques
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Digital Technology; Prosthesis User; Lip; Oral Soft Tissue Conditions; Occlusion

Keywords

three-dimensional imaging; prosthodontics; full-arch; facial scanner

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Distance between the upper lip and E-line in sagital profile

  same day

• Distance between the lower lip and E-line in sagital profile

  same day

• Naso-labial angle

  same day

Other Outcomes (1)

• Confounding factors

  same day

Interventions

Removable of the full arch implant-supported prostheses PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Implantology Institute

Lisbon, 1070-064, Portugal

RECRUITING

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia; Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• João Caramês, DDS, PhD

  Implantology Institute

  STUDY DIRECTOR

• Duarte Marques, DDS, PhD

  Implantology Institute

  STUDY CHAIR

• Rita Alves, DDS

  Implantology Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duarte Marques, DDS, PhD

CONTACT

+351 217 210 980; d.marques@institutoimplantologia.com

Rita Alves, DDS

CONTACT

rita.alves@institutoimplantologia.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 25, 2023
• Study Start: March 30, 2024
• Primary Completion: June 15, 2024
• Study Completion: December 15, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)