Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00713206
First received: July 9, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Tooth Disease
Partial Edentulism
Device: Dental Implant (Osseotite)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Integration Success of Implant [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
    Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis


Secondary Outcome Measures:
  • Crestal Bone Regression [ Time Frame: four years ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: September 2006
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dental implant (Osseotite)
Dental implants placed simultaneously with graft augmentation material.
Device: Dental Implant (Osseotite)
Root form titanium dental implant
Other Name: Osseotite
No Intervention: Control group
Dental implants placed into graft augmentation material that has four months to heal.

Detailed Description:

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713206

Locations
Italy
Università "G. d' Annunzio" Chieti-Pescara
Chieti, Italy
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Sergio Caputi, DDS Director del Dipartimento di Scienze Odontostomatologiche
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00713206     History of Changes
Other Study ID Numbers: 2604
Study First Received: July 9, 2008
Results First Received: August 6, 2013
Last Updated: October 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Biomet, Inc.:
Dental implants, maxilla, sinus lift, augmentation

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014