Splint Versus Non-splint Implant Impressions

August 17, 2018 updated by: Marco Tallarico, Hospital San Pietro Fatebenefratelli

Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00151
        • Marco Tallarico
      • Rome, RM, Italy, 00151
        • Studio odntoiatrico specialistico dr. Marco Tallarico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Snow white Plaster 2
Test
Procedure: Snow white plaster 2
Test. Plaster impression not splinted.
Active Comparator: Primopattern LC gel + PVS
Control
Procedure: Primopattern LC gel + PVS
Control PVS impression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant failure
Time Frame: 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.
Up to 5 years after implant placement

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Pietro Fatebenefratelli

Collaborators

Nobel Biocare

Investigators

  • Study Director: Marco Tallarico, dr., Private Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NobelBiocare-RCT-Procera

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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