Enhancing Prosthetic Results by Predictable Impression Technique and Reliable NobelProcera™ Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104363
Recruitment Status : Suspended (Pending approval of the Ethics Committee)
First Posted : April 15, 2010
Last Update Posted : April 15, 2010
Nobel Biocare
Information provided by:
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 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 or disease Intervention/treatment Phase
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. Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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
Study Start Date : June 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : May 2011

Arm Intervention/treatment
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:
  • Aquasil Putty DECA™
  • Aquasil Ultra LV
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:
  • Aquasil Putty DECA™
  • Aquasil Ultra LV

Primary Outcome Measures :
  1. Enhancing prosthetic results by predictable impression technique and reliable CAD/CAM systems. [ Time Frame: 3 Months ]
    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 :
  1. 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 ]
    Measure of the gap between the implant and the framework. Calculate the mean values and make analysis of variance.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01104363

Marco Tallarico
Rome, RM, Italy, 00151
San Pietro Hospital Fatebenefratelli
Rome, RM, Italy, 00189
Sponsors and Collaborators
Hospital San Pietro Fatebenefratelli
Nobel Biocare
Study Director: Marco Gargari, dr. San Pietro Hospital, Fatebenefratelli, Rome, Italy.

Responsible Party: Marco Tallarico, Odontoiatric Center, San Pietro Hospital, Fatebenefratelli (FBF) Identifier: NCT01104363     History of Changes
Other Study ID Numbers: HSPFBF-NB-01
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: March 2010

Keywords provided by Hospital San Pietro Fatebenefratelli:
Dental implants