Soft TissueNCT04050878
Three-dimensional Assessment of Facial Alterations Induced by Dental Prostheses
A study testing Facial scanner (Bellus3D) to assess perioral alterations in people with Soft Tissue, run by Implantology Institute at 1 site in Portugal.
Trial summary
Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue
- What is being tested?
- Facial scanner (Bellus3D) to assess perioral alterations
- 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
- 1 Jun 2020to 21 Jun 2020
- 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
- Patients rehabilitated with full implant supported upper dental prostheses.
Who cannot join
- Patients without beard, facial deformities, earrings or braces.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Three-dimensional Modifications Caused by Full Arch Implant Supported Dental Prosthesis With a Facial Scanner
Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper.
Read the detailed description
3 dimensional evaluation of lip support by the use of full arch impplant supported rehabilitations with the use of a facial scannner. Determination of discrepacies between the obtained facial scan and conventional measurements made by a digital caliper on the face.
- Conditions
- Soft Tissue
- Being tested
- Facial scanner (Bellus3D) to assess perioral alterations
- Keywords
- Imaging, Three-Dimensional, Technology, Dental, accuracy, extra-oral scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial scanner (Bellus3D) to assess perioral alterationsDevice
Use of a digital caliper for conventional measurements and a facial scanner (Bellus3D) to analyse the modifications induced by the use of implant supported dental prostheses in the lip support
| Study group | Role | What they receive |
|---|---|---|
| Patient with or without dental prostheses | Experimental | The patient will be submitted to two facial scans, one with and another without the dental prostheses and the obtained datasets will be compared to assess the differences. Marks will be made in the face to allow for measurements (digital and conventional) Receives: Device: Facial scanner (Bellus3D) to assess perioral alterations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue changes in µm with and without implant supported dental prostheses
Differences in the perioral soft tissues with and without dental prostheses in µm
Measured: Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jun 2020
- Primary completion20 Jun 2020
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft TissueStudies 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
- Determine the modifications caused by the use of different implant-supported dental prostheses in the soft tissues of the face, mainly upper and lower lips, by the use of a facial scanner.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implantology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo de Investigação em Bioquímica e Biologia Oral
- Responsible party
- Sponsor
- Investigators
- João Carames, DDS, Phd, Study director, Implantology InstituteDuarte Marques, DDS, PhD, Principal investigator, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050878
- Sponsor's protocol ID
- II2019-07
- Status last verified
- Jun 2020
- First submitted
- 5 Aug 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Three-dimensional Modifications Caused by Full Arch Implant Supported Dental Prosthesis With a Facial Scanner
- ClinicalTrials.gov ID
- NCT04050878
- Acronym / sponsor ID
- II2019-07
- Conditions
- Soft Tissue
- Keywords
- Imaging, Three-Dimensional, Technology, Dental, accuracy, extra-oral scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Collaborators
- Grupo de Investigação em Bioquímica e Biologia Oral
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 8 Aug 2019 (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.
Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper.
Detailed description
3 dimensional evaluation of lip support by the use of full arch impplant supported rehabilitations with the use of a facial scannner. Determination of discrepacies between the obtained facial scan and conventional measurements made by a digital caliper on the face.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determine the modifications caused by the use of different implant-supported dental prostheses in the soft tissues of the face, mainly upper and lower lips, by the use of a facial scanner.
| Arm | Type | Receives |
|---|---|---|
| Patient with or without dental prostheses | Experimental | Device: Facial scanner (Bellus3D) to assess perioral alterationsThe patient will be submitted to two facial scans, one with and another without the dental prostheses and the obtained datasets will be compared to assess the differences. Marks will be made in the face to allow for measurements (digital and conventional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients rehabilitated with full implant supported upper dental prostheses.
Key exclusion criteria (1 listed)
- Patients without beard, facial deformities, earrings or braces.
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 scanner (Bellus3D) to assess perioral alterationsUse of a digital caliper for conventional measurements and a facial scanner (Bellus3D) to analyse the modifications induced by the use of implant supported dental prostheses in the lip support | Device | Patient with or without dental prostheses |
Primary outcome
Soft tissue changes in µm with and without implant supported dental prostheses
Time frame: Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses
Differences in the perioral soft tissues with and without dental prostheses in µm
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 30 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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 Carames, 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 (Bellus3D) to assess perioral alterations in people with Soft Tissue, 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 30 Jun 2020. 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?
Soft tissue changes in µm with and without implant supported dental prostheses (time frame: Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses). 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 30 Jun 2020.