Splint Versus Non-splint Implant Impressions

NCT ID: NCT01104363

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Dental Implants Dental Impression Materials Dental Impression Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Snow white Plaster 2

Test

Group Type EXPERIMENTAL

Snow white plaster 2

Intervention Type PROCEDURE

Test. Plaster impression not splinted.

Primopattern LC gel + PVS

Control

Group Type ACTIVE_COMPARATOR

Primopattern LC gel + PVS

Intervention Type PROCEDURE

Control PVS impression

Interventions

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Snow white plaster 2

Test. Plaster impression not splinted.

Intervention Type PROCEDURE

Primopattern LC gel + PVS

Control PVS impression

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nobel Biocare

INDUSTRY

Sponsor Role collaborator

Hospital San Pietro Fatebenefratelli

OTHER

Sponsor Role lead

Responsible Party

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Marco Tallarico

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Tallarico, dr.

Role: STUDY_DIRECTOR

Private Practice

Locations

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Marco Tallarico

Rome, RM, Italy

Site Status

Studio odntoiatrico specialistico dr. Marco Tallarico

Rome, RM, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18922257 (View on PubMed)

Other Identifiers

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NobelBiocare-RCT-Procera

Identifier Type: -

Identifier Source: org_study_id

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