ClinicalTrials.gg
RecruitingNCT06052501Updated Jun 26, 2024

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

An observational study in Digital Technology, Prosthesis User and Lip, sponsored by Implantology Institute. Recruiting at 1 site in Portugal. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Implantology Institute · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • three-dimensional imaging
  • prosthodontics
  • full-arch
  • facial scanner
03

In context

Lead sponsor

Implantology Institute is the lead sponsor of 17 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Individuals with history of 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • ProcedureRemovable 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.

06

What researchers measure

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)

    Time frame: same day

Secondary outcomes

  1. 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)

    Time frame: same day

  2. 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)

    Time frame: same day

  3. Naso-labial angle

    The fourth outcome is to quantify the changes in the naso-labial angle related to the absence of the fixed prostheses

    Time frame: same day

Other outcomes

  1. Confounding factors

    Type of definitive rehabilitation, time of implant surgery, extension of rehabilitation/edentulism

    Time frame: same day

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06052501
Lead sponsor
Implantology Institute
Responsible party
Sponsor
First posted
Sep 25, 2023
Start date
Mar 30, 2024
Primary completion
Jun 15, 2024
Completion
Dec 15, 2024 (estimated)
Last update
Jun 26, 2024

Study contacts

Duarte Marques, DDS, PhD
Contact
d.marques@institutoimplantologia.com
+351 217 210 980
João Caramês, DDS, PhD
study director · Implantology Institute
Duarte Marques, DDS, PhD
study chair · Implantology Institute
Rita Alves, DDS
principal investigator · Implantology Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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