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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00725049
First received: July 28, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


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

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, Multicenter, Randomized Multicenter Study of Short Implants Used to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

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


Secondary Outcome Measures:
  • Cost Analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dental implant (Nanotite)
Dental implants of short length placed without sinus lifts
Device: Dental Implant (Nanotite)
Root form titanium dental implant
Other Name: Nanotite
No Intervention: Control group
Dental implants of standard length placed simultaneously with sinus augmentation

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

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 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
  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: NCT00725049

Locations
Spain
Universidad Complutense de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Mariano A Sanz, MD, DDS Universidad Complutense de Madrid
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00725049     History of Changes
Other Study ID Numbers: 2611
Study First Received: July 28, 2008
Results First Received: August 6, 2013
Last Updated: October 29, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Biomet, Inc.:
dental implants
Nanotite Certain implant
Osseotite
multicenter
randomized
clinical study
partial edentulism
crestal bone level
short fixed bridge
cost analysis

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 23, 2014