An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation (Romeo)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc.

ClinicalTrials.gov Identifier:

NCT00725049

First received: July 28, 2008

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 28, 2008

Last Updated Date

July 12, 2012

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Integration success of implant [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00725049 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cost analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation

Official Title ^ICMJE

A Prospective, Multicenter, Randomized Multicenter Study of Short Implants Used to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.

Brief Summary

This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed.

Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

Detailed Description

In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Tooth Disease
Partial Edentulism

Intervention ^ICMJE

Device: Dental Implant (Nanotite)

Root form titanium dental implant

Other Name: Nanotite

Study Arm (s)

Active Comparator: Test group
Dental implants of short length placed without sinus lifts

Intervention: Device: Dental Implant (Nanotite)
No Intervention: Control group
Dental implants of standard length placed simultaneously with sinus augmentation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients of either sex and any race greater than 18 years of age
patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis
patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant
patients must be physically able to tolerate conventional surgical and restorative procedures

Exclusion Criteria:

patients with active infection or severe inflammation in the areas intended for implant placement
patients with a > 10 cigarettes per day smoking habit
patients with uncontrolled diabetes or metabolic bone disease
patient with a history of therapeutic radiation to the head
patients who are known to be pregnant
patients with para-functional habits with evidence of severe bruxing or clenching
patients not able to commit to a 3 year follow-up program

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00725049

Other Study ID Numbers ^ICMJE

2611

Has Data Monitoring Committee

Yes

Responsible Party

Biomet, Inc.

Study Sponsor ^ICMJE

Biomet, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mariano A Sanz, MD, DDS

Universidad Complutense de Madrid

Information Provided By

Biomet, Inc.

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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