An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation - Full Text View

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00725049

Purpose

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.

Condition	Intervention
Dental Implants Edentulism	Device: Dental Implant (Nanotite)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test group: Active Comparator Dental implants of short length placed without sinus lifts	Device: Dental Implant (Nanotite) Root form titanium dental implant
Control group: No Intervention Dental implants of standard length placed simultaneously with sinus augmentation

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725049

Locations

Spain
Universidad Complutense de Madrid	Recruiting
Madrid, Spain, 28040
Contact: Mariano A Sanz, MD, DDS +34 (91) 3941901 marianosanz@odon.ucm.es
Principal Investigator: Mariano A Sanz, MD, DDS

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Mariano A Sanz, MD, DDS

Universidad Complutense de Madrid

More Information

No publications provided

Responsible Party:	Biomet 3i, Inc. ( Jim Kenealy, Pharm.D.; Director Clinical Research )
Study ID Numbers:	2611
Study First Received:	July 28, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00725049 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Biomet, Inc.:

dental implants
Nanotite Certain implant
Osseotite
multicenter
randomized

clinical study
partial edentulism
crestal bone level
short fixed bridge
cost analysis

ClinicalTrials.gov processed this record on February 08, 2010