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

This study has suspended participant recruitment.
(Pending approval of the Ethics Committee)
Sponsor:
Collaborator:
Nobel Biocare
Information provided by:
Hospital San Pietro Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01104363
First received: April 2, 2010
Last updated: April 13, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Hospital San Pietro Fatebenefratelli:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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

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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104363

Locations
Italy
Marco Tallarico
Rome, RM, Italy, 00151
San Pietro Hospital Fatebenefratelli
Rome, RM, Italy, 00189
Sponsors and Collaborators
Hospital San Pietro Fatebenefratelli
Nobel Biocare
Investigators
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 November 19, 2014