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N/A N=6 Screening

Customized Impressions in Dental Implants - Soft Tissues Changes

Soft Tissue

Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Changes in Soft Tissues Around Implant — 243.89 root mean square in µm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Dental implant impressions- Different Techniques (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Implantology Institute
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Soft Tissues Around Implant
243.89
SECONDARY
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant
51.08

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. 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).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03496428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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