Clinical trial NCT00725049: An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Disease
Partial Edentulism
Keywords: dental implants
Nanotite Certain implant
Osseotite
multicenter
randomized
clinical study
partial edentulism
crestal bone level
short fixed bridge
cost analysis
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Integration Success of Implant
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Mariano A Sanz, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References: