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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725049
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : October 11, 2013
Last Update Posted : July 18, 2018
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Tooth Disease Partial Edentulism Device: Dental Implant (Nanotite) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : February 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Cost Analysis [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725049

Universidad Complutense de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Zimmer Biomet
Principal Investigator: Mariano A Sanz, MD, DDS Universidad Complutense de Madrid

Responsible Party: Zimmer Biomet Identifier: NCT00725049     History of Changes
Other Study ID Numbers: 2611
First Posted: July 30, 2008    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: July 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
dental implants
Nanotite Certain implant
clinical study
partial edentulism
crestal bone level
short fixed bridge
cost analysis

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases