Enhancing Prosthetic Results by Predictable Impression Technique and Reliable NobelProcera™ Systems
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Dental Implants Dental Impression Materials Dental Impression Techniques |
Procedure: Snow white plaster 2. Kerr Co. Romulus, MI, USA. Procedure: Primopattern LC gel Procedure: Smart Dentin Replacement. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Heavy Vinyl PolySiloxane and Splinted Implants Impression Technique in Edentulous Patients Rehabilitated With the All-on-4 Concept and Procera® Implant Bridge |
- Enhancing prosthetic results by predictable impression technique and reliable CAD/CAM systems. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Sheffield's test: measurements of the precision of fit between completed implant prostheses and the master cast in routine edentulous situations through intra-oral radiographs.
- Secondary outcome measures: comparison of the titanium frameworks fit accuracy by a cross-test on the two casts and Scanning Electron Microscopy (SEM) analysis. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Measure of the gap between the implant and the framework. Calculate the mean values and make analysis of variance.
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Snow white Plaster 2
Dental impression material. Plaster. Kerr Co. Romulus, MI, USA.
|
Procedure: Snow white plaster 2. Kerr Co. Romulus, MI, USA.
Pick-up, splinted implants impressions.
Other Name: Vinyl PolySiloxane, Zhermack®
|
|
Active Comparator: Primopattern LC gel + PVS
Light cured universal modeling resin, Primotec, Bad Homburg, Germany.
|
Procedure: Primopattern LC gel
Pick-up, splinted implants impressions.
Other Names:
|
|
Active Comparator: Smart Dentin Replacement + PVS
Smart Dentin Replacement, SDR. Light cured dental composite resin. Dentsply International Inc, Caulk, USA.
|
Procedure: Smart Dentin Replacement.
Pick-up, splinted implants impressions.
Other Names:
|
Detailed Description:
Background: Various implant impression techniques and materials have been proposed. Some clinical factors, such as the angulation or depth of implants, may affect the accuracy of the implant impressions. Lee et al. (Lee JPD 2008) reported that the splint-technique ensures a greater accuracy if compared to the non-splint technique, and, in case of 4 or more implants, the pick-up technique proves most appropriate. Polyether (PE) and VPS were the recommended materials for the implant impressions.
Aim: 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.
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Italy | |
| Marco Tallarico | |
| Rome, RM, Italy, 00151 | |
| San Pietro Hospital Fatebenefratelli | |
| Rome, RM, Italy, 00189 | |
| Study Director: | Marco Gargari, dr. | San Pietro Hospital, Fatebenefratelli, Rome, Italy. |
More Information
Publications:
| Responsible Party: | Marco Tallarico, Odontoiatric Center, San Pietro Hospital, Fatebenefratelli (FBF) |
| ClinicalTrials.gov Identifier: | NCT01104363 History of Changes |
| Other Study ID Numbers: | HSPFBF-NB-01 |
| Study First Received: | April 2, 2010 |
| Last Updated: | April 13, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Hospital San Pietro Fatebenefratelli:
|
Dental implants |
ClinicalTrials.gov processed this record on May 16, 2013