Soft Tissue Clinical Trial
Official title:
Customized Impressions in Dental Implants - Soft Tissues Changes
Verified date | August 2019 |
Source | Implantology Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 6 |
Est. completion date | September 1, 2018 |
Est. primary completion date | August 25, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Patients without soft tissue contouring or without provisional implant supported use |
Country | Name | City | State |
---|---|---|---|
Portugal | Instituto de Implantologia | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Implantology Institute | Grupo de Investigação em Bioquímica e Biologia Oral |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Both techniques will be used in the same appointment upon 3 months use of provisional crown | |
Secondary | 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 | Both techniques will be used in the same appointment upon 3 months use of provisional crown |
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