Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Implant failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Snow white Plaster 2
Test
Intervention: Snow white plaster 2 (Procedure)
Primopattern LC gel + PVS
Control
Intervention: Primopattern LC gel + PVS (Procedure)
Outcomes
Primary Outcomes
Implant failure
Time Frame: Up to 5 years after implant placement
An 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 Outcomes
- Chair-time(4 to 5 months after implant placement (baseline))
- Inter-implants distance between groups(4 to 5 months after implant placement (baseline))
Investigators
Marco Tallarico
Principal investigator
Hospital San Pietro Fatebenefratelli