Official Title: “A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites”

This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases.

Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side.

Each patient (or side if a bilateral case) will be randomly assigned to one of two groups:

Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.

Intervention(s) in this Clinical Trial

• Device: Dental Implant (Osseotite)
  • Root form titanium dental implant

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Dental implants placed simultaneously with graft augmentation material.
• No Intervention: 2
  • Dental implants placed into graft augmentation material that has four months to heal.

Primary Measures

• Osseous integration
  • Time Frame: One year
    Safety Issue?: Yes

Secondary Measures

• Crestal bone regression
  • Time Frame: four years
    Safety Issue?: No

Inclusion Criteria:

• Patients of either sex and any race greater than 18 years of age
• Patients for whom a decision has already been made to augment one or both maxillary sinuses for the purpose of placing dental implants in a maxillary ridge no less than 3 mm high and no greater than 5 mm in height
• Patients must be physically able to tolerate conventional surgical and restorative procedures.
• Patients must agree to be evaluated for each study visit, especially the yearly follow-up visit

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 mellitus.
• Treatment with therapeutic radiation to the head within the past 12 months.
• Patients who are pregnant at the screening visit.
• Patients with evidence of severe para-functional habits such as bruxing or clenching.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet 3i, LLC

Overall Clinical Trial Officials and Contacts

Sergio Caputi, DDS Principal Investigator Director del Dipartimento di Scienze Odontostomatologiche  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00713206

Study ID Number: 2604

ClinicalTrials.gov Identifier: NCT00713206

Health Authority: Italy: Ethics Committee