Clinical trial NCT01104363: Splint Versus Non-splint Implant Impressions
Official title: Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Implants
Dental Impression Materials
Dental Impression Techniques
Keywords: Dental implants
Lead sponsor: Hospital San Pietro Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
First posted: 2010-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant failure
timeFrame: Up to 5 years after implant placement
Secondary outcomes:
measure: Inter-implants distance between groups
timeFrame: 4 to 5 months after implant placement (baseline)
measure: Chair-time
timeFrame: 4 to 5 months after implant placement (baseline)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tallarico
state: RM
city: Rome
country: Italy
facility: Studio odntoiatrico specialistico dr. Marco Tallarico
state: RM
Study officials:
affiliation: Private Practice
name: Marco Tallarico, dr.
role: STUDY_DIRECTOR
References:
citation: 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.