Splint Versus Non-splint Implant Impressions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Implants, Dental Impression Materials, Dental Impression Techniques

Intervention / Treatment
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* Procedure: Snow white plaster 2
* Procedure: Primopattern LC gel + PVS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snow white Plaster 2<br>Test | Procedure: Snow white plaster 2<br>* Test. Plaster impression not splinted.<br>|
| Active Comparator: Primopattern LC gel + PVS<br>Control | Procedure: Primopattern LC gel + PVS<br>* Control PVS impression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant failure | 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. | Up to 5 years after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-implants distance between groups | Inter-implants distance between groups assessed both on casts and digital photos measured in mm. | 4 to 5 months after implant placement (baseline) | 
| Chair-time | Time needed to take impression in both control and test group measured in seconds. | 4 to 5 months after implant placement (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants