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Splint Versus Non-splint Implant Impressions

Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104363
Enrollment
0
Registered
2010-04-15
Start date
2010-06-30
Completion date
2011-05-31
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Dental Impression Materials, Dental Impression Techniques

Keywords

Dental implants

Brief summary

The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded, randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All patients were monitored from implant placement until prosthetic loading.

Detailed description

The aim of the present study was to investigate the accuracy of pick-up, splinted implants, and heavy VPS impression techniques (Aquasil Putty DECA™ and Aquasil Ultra Light Viscosity (LV) Regular Set, Dentsply International Inc, Caulk, USA); to compare two splint materials for implants: Primopattern LC gel (Primotec, Bad Homburg, Germany), and Smart Dentin Replacement (SDR™, Dentsply International Inc, Caulk, USA); to examine the clinical factors affecting the accuracy of implant impressions; to test the tension-free fit of the new scanner and software NobelProcera™ (NobelBiocare, AB, Göteborg, Sweden) titanium frameworks.The hypothesis to demonstrate is that all impression techniques and used materials reduce time for final restoration and improve the accuracy of the impression.

Interventions

PROCEDURESnow white plaster 2

Test. Plaster impression not splinted.

PROCEDUREPrimopattern LC gel + PVS

Control PVS impression

Sponsors

Nobel Biocare
CollaboratorINDUSTRY
Hospital San Pietro Fatebenefratelli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 21 years or older. * Both genders. * Fully edentulous patients. * Both maxilla and mandible. * Dental implant rehabilitation utilizing the All-on-4 concept at least 8 weeks before impression. * External hex dental implant. * Patients with ability to understand and sign the informed consent prior to starting the study. * Adequate oral hygiene. * Immediate functional loading. * Implant stability quote value =/\> 65 from implant placement to final prosthetic rehabilitation.

Exclusion criteria

* Failure of one or more inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Implant failureUp to 5 years after implant placementAn implant was consid- ered to be a failure if it was lost owing to mobility, implant fracture and/or any infection requiring implant removal.

Secondary

MeasureTime frameDescription
Inter-implants distance between groups4 to 5 months after implant placement (baseline)Inter-implants distance between groups assessed both on casts and digital photos measured in mm.
Chair-time4 to 5 months after implant placement (baseline)Time needed to take impression in both control and test group measured in seconds.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026