Digital TechnologyNCT06052501
3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
An observational study of Digital Technology and Prosthesis User, run by Implantology Institute at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Digital Technology, Prosthesis User, Lip
- What is being tested?
- Removable of the full arch implant-supported prostheses
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Mar 2024to 15 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Rita Alves, DDS contact
Portugal1 site, 1 recruiting
- Recruiting
Implantology Institute
Lisbon, 1070-064
Duarte Marques, DDS, PhD, +351 217 210 980, d.marques@institutoimplantologia.com
Rita Alves, DDS, +351 217 210 980, rita.alves@institutoimplantologia.com
About this study
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.
- Conditions
- Digital Technology, Prosthesis User, Lip, Oral Soft Tissue Conditions, Occlusion
- Being tested
- Removable of the full arch implant-supported prostheses
- Keywords
- three-dimensional imaging, prosthodontics, full-arch, facial scanner
- Medical subject headings
- Lymphoid Interstitial Pneumonia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable of the full arch implant-supported prosthesesProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: same day
Secondary outcomes (3)
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)
Measured: same day
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)
Measured: same day
Naso-labial angle
The fourth outcome is to quantify the changes in the naso-labial angle related to the absence of the fixed prostheses
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start30 Mar 2024
- Primary completion15 Jun 2024
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital TechnologyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
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, Study chair, Implantology InstituteRita Alves, DDS, Principal investigator, Implantology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052501
- Sponsor's protocol ID
- DMarques
- Status last verified
- Jun 2024
- First submitted
- 19 Sep 2023
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
- ClinicalTrials.gov ID
- NCT06052501
- Acronym / sponsor ID
- DMarques
- Conditions
- Digital Technology, Prosthesis User, Lip, Oral Soft Tissue Conditions, Occlusion
- Keywords
- three-dimensional imaging, prosthodontics, full-arch, facial scanner
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 25 Sep 2023 (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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Removable of the full arch implant-supported prosthesesThe 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. | Procedure or surgery | – |
Primary outcome
Volumetric changes in peri-oral area
Time frame: same day
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)
3 secondary outcomes
Distance between the upper lip and E-line in sagital profile
Time frame: same day
Distance between the lower lip and E-line in sagital profile
Time frame: same day
Naso-labial angle
Time frame: same day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Rita Alves, DDS contact
João Caramês, DDS, PhD study director
Implantology Institute
Duarte Marques, DDS, PhD study chair
Implantology Institute
Rita Alves, DDS 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?
An observational study of Digital Technology 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duarte Marques, DDS, PhD (+351 217 210 980, d.marques@institutoimplantologia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric changes in peri-oral area (time frame: same day). 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 26 Jun 2024.