A Prospective Study Evaluating the Integration Success and Maintenance of Short Length NanoTite Dental Implants Into Maxillary Sites That Would Otherwise Require Sinus Augmentation.
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Implants; Edentulism
Intervention: Dental Implant (Nanotite) (Device); Dental implant Nanotite (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Biomet 3i, LLC Official(s) and/or principal investigator(s):
Mariano A Sanz, MD, DDS, Principal Investigator, Affiliation: Universidad Complutense de Madrid
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.
Clinical Details
Official title: A Prospective, Multicenter, Randomized-Controlled Multicenter Study of the Use of Short Implants to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Integration success of implant
Secondary outcome: Cost analysis
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Universidad Complutense de Madrid, Madrid 28040, Spain
Additional Information
Starting date: September 2008
Ending date: October 2012
Last updated: July 28, 2008
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