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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Tooth Disease, Partial Edentulism

Intervention / Treatment
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* Device: Dental Implant (Nanotite)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dental implant (Nanotite)<br>Dental implants of short length placed without sinus lifts | Device: Dental Implant (Nanotite)<br>* Root form titanium dental implant<br>* Other names: Nanotite;|
| No Intervention: Control group<br>Dental implants of standard length placed simultaneously with sinus augmentation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration Success of Implant | Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level, short fixed bridge, cost analysis