Soft TissueNCT03496428
Customized Impressions in Dental Implants - Soft Tissues Changes
A study testing Dental implant impressions- Different Techniques in people with Soft Tissue, run by Implantology Institute at 1 site in Portugal.
Trial summary
Six patients with a single unit implant in the anterior maxilla (from premolar to premolar), after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions. Informed consents and local ethical committee clearance will be obtained. 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?
- Dental implant impressions- Different Techniques
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jun 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with single implant with adjacent teeth in the anterior esthetic area (Pre-Molar to Pre-Molar) of the upper arch with provisional implant crown use and indication for rehabilitation for definitive implant supported crown.
Who cannot join
- Patients without soft tissue contouring or without provisional implant supported use
Trial locations and contacts
1 site in 1 country.
About this study
Six patients with a single unit implant in the anterior maxilla (from premolar to premolar), after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions.
Informed consents and local ethical committee clearance will be obtained. Patients will be submitted to a silicon impression with a customized impression coping from which a conventional cast will be obtained and scanned with D2000 (3Shape) and to an intraoral scan with Trios (3Shape). Standard Tessellation Language (STL) files will be obtained from both procedures and imported to reverse engineering software Geomagic Control X (3D Systems) and the distance between both scans will be calculated in a colored 3D map. From this map, two outcomes will be analyzed: the changes in soft tissues around implants with the two techniques (primary outcome) and the discrepancy between both scans in the teeth adjacent to the implants (secondary outcome).
Read the detailed description
"Custom-guided" tissue healing with o provisional restoration is the most predictable way to achieve natural anatomically shaped tissue and optimal esthetics. Several authors describe the use of an anatomically contoured provisional restoration to start to guide the soft tissue healing in an ideal, natural morphology that replicates the tooth form. Being that, after shaping the tissue to ideal anatomic form and health the exact duplication of the soft tissue contour should be obtained so that laboratory can duplicate it in the final restoration. Nowadays gold-standard, describes the use of a customized impression coping that replicates the provisional soft tissue contour by the use of and analog-silicone index upon which a gypsum cast is created.
The use of computer-aided design/computer-assisted manufacture (CAD/CAM) technologies to manufacture prosthetic frameworks on dental implants is noticeably increasing. This method requires the use of an STL file which can be acquired intra-orally or extraorally using a stone cast poured from a conventional implant impression using a customized implant impression coping.
Several studies have already described the accuracy of STL data and that evaluating STL models can be done by best fit algorithms in appropriate softwares.
In this pilot study, the investigators aim to evaluate soft tissue profile changes in single unit implants in the aesthetic area using a customized impression coping with conventional methods and the intraoral impression with an intraoral scanner (Trios, 3Shape). Additionally position discrepancies of adjacent teeth between the two techniques will be assessed.
This pilot study will include 6 patients with single unit implant which will be recruited according inclusion criteria and submitted to the two different impression techniques. Conventional stone cast will be scanned with a laboratory scanner D2000 (3Shape) with a described deviation of 5μm. Two STL files will be obtained per patient and by established methods with a reverse engineering software (Geomagic Control X, 3D Systems) discrepancies between them assessed.
Differences in axis (x, y, z) and overall distances will be assessed in the soft tissues (18 points) and in adjacent teeth (26 points) according established methods, per patient. Additionally, 3D colored maps will be produced to ascertain volumetric changes between techniques. T-test and Wilcoxon signed-rank test will be used and the level of statistical significance set at P<0.05. Sample size determination will be performed based on obtained results.
- Conditions
- Soft Tissue
- Being tested
- Dental implant impressions- Different Techniques
- Keywords
- intra-oral scanner, customized impression coping, extra-oral scanner, accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant impressions- Different TechniquesDevice
Assessment of soft tissues changes with different techniques
| Study group | Role | What they receive |
|---|---|---|
| Dental implant Impression Techniques | Other | Dental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000.
An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined Receives: Device: Dental implant impressions- Different Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Soft Tissues Around Implant
Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.
Measured: Both techniques will be used in the same appointment upon 3 months use of provisional crown
Secondary outcomes (1)
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant
Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations
Measured: Both techniques will be used in the same appointment upon 3 months use of provisional crown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start2 Jun 2017
- Primary completion25 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To describe the soft tissues dimensional changes (based on STL files) occurred between an intra-oral scanner and standartized scan-body and a extra-oral scanner of stone cast poured from silicone impression with a customized impression coping 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations
- Masking
- None (open label)
- Enrolment
- 6 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
- Duarte Marques, DDS, PhD, Principal investigator, Implantology InstituteJoão Caramês, DDS, PhD, Study director, Implantology InstituteAntonio Mata, DDS, PhD, Principal investigator, Grupo de Investigação em Bioquímica e Biologia Oral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496428
- Sponsor's protocol ID
- II2017-06
- Status last verified
- Aug 2019
- First submitted
- 31 Mar 2018
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Impressions in Dental Implants - Soft Tissues Changes
- ClinicalTrials.gov ID
- NCT03496428
- Acronym / sponsor ID
- II2017-06
- Conditions
- Soft Tissue
- Keywords
- intra-oral scanner, customized impression coping, extra-oral scanner, accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Implantology InstituteUniversity, hospital or other
- Collaborators
- Grupo de Investigação em Bioquímica e Biologia Oral
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Six patients with a single unit implant in the anterior maxilla (from premolar to premolar), after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions.
Informed consents and local ethical committee clearance will be obtained. Patients will be submitted to a silicon impression with a customized impression coping from which a conventional cast will be obtained and scanned with D2000 (3Shape) and to an intraoral scan with Trios (3Shape). Standard Tessellation Language (STL) files will be obtained from both procedures and imported to reverse engineering software Geomagic Control X (3D Systems) and the distance between both scans will be calculated in a colored 3D map. From this map, two outcomes will be analyzed: the changes in soft tissues around implants with the two techniques (primary outcome) and the discrepancy between both scans in the teeth adjacent to the implants (secondary outcome).
Detailed description
"Custom-guided" tissue healing with o provisional restoration is the most predictable way to achieve natural anatomically shaped tissue and optimal esthetics. Several authors describe the use of an anatomically contoured provisional restoration to start to guide the soft tissue healing in an ideal, natural morphology that replicates the tooth form. Being that, after shaping the tissue to ideal anatomic form and health the exact duplication of the soft tissue contour should be obtained so that laboratory can duplicate it in the final restoration. Nowadays gold-standard, describes the use of a customized impression coping that replicates the provisional soft tissue contour by the use of and analog-silicone index upon which a gypsum cast is created.
The use of computer-aided design/computer-assisted manufacture (CAD/CAM) technologies to manufacture prosthetic frameworks on dental implants is noticeably increasing. This method requires the use of an STL file which can be acquired intra-orally or extraorally using a stone cast poured from a conventional implant impression using a customized implant impression coping.
Several studies have already described the accuracy of STL data and that evaluating STL models can be done by best fit algorithms in appropriate softwares.
In this pilot study, the investigators aim to evaluate soft tissue profile changes in single unit implants in the aesthetic area using a customized impression coping with conventional methods and the intraoral impression with an intraoral scanner (Trios, 3Shape). Additionally position discrepancies of adjacent teeth between the two techniques will be assessed.
This pilot study will include 6 patients with single unit implant which will be recruited according inclusion criteria and submitted to the two different impression techniques. Conventional stone cast will be scanned with a laboratory scanner D2000 (3Shape) with a described deviation of 5μm. Two STL files will be obtained per patient and by established methods with a reverse engineering software (Geomagic Control X, 3D Systems) discrepancies between them assessed.
Differences in axis (x, y, z) and overall distances will be assessed in the soft tissues (18 points) and in adjacent teeth (26 points) according established methods, per patient. Additionally, 3D colored maps will be produced to ascertain volumetric changes between techniques. T-test and Wilcoxon signed-rank test will be used and the level of statistical significance set at P<0.05. Sample size determination will be performed based on obtained results.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To describe the soft tissues dimensional changes (based on STL files) occurred between an intra-oral scanner and standartized scan-body and a extra-oral scanner of stone cast poured from silicone impression with a customized impression coping 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations
| Arm | Type | Receives |
|---|---|---|
| Dental implant Impression Techniques | Other | Device: Dental implant impressions- Different TechniquesDental implant impressions- Different Techniques An customized impression coping will be created based on the provisional crown emergence profile which will be used to perform a silicone implant impression. A conventional cast will be created based on the silicone impression and an extra-oral scanner reading will be performed with a 3shape D2000. An intra-oral scanner (Trios, 3Shape) will be used to scan the entire arch. The STL file created will be compared and tooth positions and soft tissues discrepancies will be determined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with single implant with adjacent teeth in the anterior esthetic area (Pre-Molar to Pre-Molar) of the upper arch with provisional implant crown use and indication for rehabilitation for definitive implant supported crown.
Key exclusion criteria (1 listed)
- Patients without soft tissue contouring or without provisional implant supported use
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 |
|---|---|---|
| Dental implant impressions- Different TechniquesAssessment of soft tissues changes with different techniques | Device | Dental implant Impression Techniques |
Primary outcome
Changes in Soft Tissues Around Implant
Time frame: Both techniques will be used in the same appointment upon 3 months use of provisional crown
Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.
1 secondary outcome
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant
Time frame: Both techniques will be used in the same appointment upon 3 months use of provisional crown
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Duarte Marques, DDS, PhD principal investigator
Implantology Institute
João Caramês, DDS, PhD study director
Implantology Institute
Antonio Mata, DDS, PhD principal investigator
Grupo de Investigação em Bioquímica e Biologia Oral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant impressions- Different Techniques 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 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Soft Tissues Around Implant (time frame: Both techniques will be used in the same appointment upon 3 months use of provisional crown). 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 Oct 2019.