An interventional study of Dental implant impressions- Different Techniques in Soft Tissue, sponsored by Implantology Institute. Completed at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Implantology Institute · Not applicable, Interventional, and Screening
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).
"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.
Exclusion Criteria:
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
Device: Dental implant impressions- Different Techniques
Assessment of soft tissues changes with different techniques
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.
Time frame: Both techniques will be used in the same appointment upon 3 months use of provisional crown
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
Time frame: Both techniques will be used in the same appointment upon 3 months use of provisional crown
be at least 18 years of age; have at least one implant in the anterior maxilla with the indication for rehabilitation with a definitive implant supported crown; have two mesial and two distal adjacent teeth to the implant and be rehabilitated with a provisional implant supported crown for at least 3 months.
| Milestone | Dental Implant Impression Techniques |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| root mean square in µm | Dental Implant Impression Techniques |
|---|---|
| Changes in Soft Tissues Around Implant | 243.89 (209.15 to 278.63) |
Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations
| Root mean square in μm | Dental Implant Impression Techniques |
|---|---|
| Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant | 51.08 (45.68 to 56.47) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dental Implant Impression Techniques | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Dental Implant Impression Techniques |
|---|---|
| Mean | 51 (23 to 76) |
| Sex: Female, Male(Participants) | Dental Implant Impression Techniques |
|---|---|
| Female | 5 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | Dental Implant Impression Techniques |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Implantology Institute