LipNCT04753866
Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations
A study testing Facial scanner in people with Lip and Prosthesis User, run by Implantology Institute at 1 site in Portugal.
Trial summary
Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip, Prosthesis User, Soft Tissue
- What is being tested?
- Facial scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Jun 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for full arch implant rehabilitation
Who cannot join
- Presence of facial hair, braces, make up, earrings or any facial deformity
Trial locations and contacts
1 site in 1 country.
About this study
Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.
Read the detailed description
As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements.
- Conditions
- Lip, Prosthesis User, Soft Tissue
- Being tested
- Facial scanner
- Keywords
- Dental Esthetics, Dental Implants, Three-Dimensional Imaging, Oral Surgery
- Medical subject headings
- Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial scannerDevice
The Bellus3D facial scanner will be used to scan the patient before and after implant rehabilitation in order to produce .obj files that allow 3D comparisons and to obtain discrepancy values regarding lip support.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitated | Experimental | Initial lip support condition of the patient when presents himself/herself at the office with indication for full arch implant rehabilitation. Then, the patient is facially scanned before and after the implant surgery. Receives: Device: Facial scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lip Support Changes in 3D (μm)
Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)
Measured: 1 month
Secondary outcomes (1)
Facial Alterations in 2D (mm)
Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start20 Jun 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Caramês, DDS PhD, Study director, Implantology InstituteDuarte Marques, DDS PhD, Principal investigator, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753866
- Sponsor's protocol ID
- II2020-06
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations
- ClinicalTrials.gov ID
- NCT04753866
- Acronym / sponsor ID
- II2020-06
- Conditions
- Lip, Prosthesis User, Soft Tissue
- Keywords
- Dental Esthetics, Dental Implants, Three-Dimensional Imaging, Oral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.
Detailed description
As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitated | Experimental | Device: Facial scannerInitial lip support condition of the patient when presents himself/herself at the office with indication for full arch implant rehabilitation. Then, the patient is facially scanned before and after the implant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for full arch implant rehabilitation
Key exclusion criteria (1 listed)
- Presence of facial hair, braces, make up, earrings or any facial deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial scannerThe Bellus3D facial scanner will be used to scan the patient before and after implant rehabilitation in order to produce .obj files that allow 3D comparisons and to obtain discrepancy values regarding lip support. | Device | Rehabilitated |
Primary outcome
Lip Support Changes in 3D (μm)
Time frame: 1 month
Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)
1 secondary outcome
Facial Alterations in 2D (mm)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Lip
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Not yet recruitingPhase 1/2
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Caramês, DDS PhD study director
Implantology Institute
Duarte Marques, DDS PhD principal investigator
Implantology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial scanner in people with Lip and Prosthesis User, run by Implantology Institute at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lip Support Changes in 3D (μm) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.