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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01104363
Other study ID # NobelBiocare-RCT-Procera
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2010
Est. completion date May 2011

Study information

Verified date August 2018
Source Hospital San Pietro Fatebenefratelli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2011
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 90 Years
Eligibility 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


Intervention

Procedure:
Snow white plaster 2
Test. Plaster impression not splinted.
Primopattern LC gel + PVS
Control PVS impression

Locations

Country Name City State
Italy Marco Tallarico Rome RM
Italy Studio odntoiatrico specialistico dr. Marco Tallarico Rome RM

Sponsors (2)

Lead Sponsor Collaborator
Hospital San Pietro Fatebenefratelli Nobel Biocare

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary Chair-time Time needed to take impression in both control and test group measured in seconds. 4 to 5 months after implant placement (baseline)
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