Splint Versus Non-splint Implant Impressions

Not Applicable

Withdrawn

• Conditions: Dental Impression Materials; Dental Impression Techniques; Dental Implants

• Registration Number: NCT01104363
• Lead Sponsor: Hospital San Pietro Fatebenefratelli

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 Timeline

• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2011-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Implant failure	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 Outcome Measures

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

Trial Locations

Locations (2)

Marco Tallarico; 🇮🇹 Rome, RM, Italy

Studio odntoiatrico specialistico dr. Marco Tallarico; 🇮🇹 Rome, RM, Italy