Back to resultsAn Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation (Romeo)
Primary Purpose
Tooth Disease, Partial Edentulism
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dental Implant (Nanotite)
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Disease focused on measuring dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level, short fixed bridge, cost analysis
Eligibility 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
Sites / Locations
- Universidad Complutense de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Dental implant (Nanotite)
Control group
Arm Description
Dental implants of short length placed without sinus lifts
Dental implants of standard length placed simultaneously with sinus augmentation
Outcomes
Primary Outcome Measures
Integration Success of Implant
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00725049
Brief Title
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
Acronym
Romeo
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Disease, Partial Edentulism
Keywords
dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level, short fixed bridge, cost analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental implant (Nanotite)
Arm Type
Active Comparator
Arm Description
Dental implants of short length placed without sinus lifts
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Dental implants of standard length placed simultaneously with sinus augmentation
Intervention Type
Device
Intervention Name(s)
Dental Implant (Nanotite)
Other Intervention Name(s)
Nanotite
Intervention Description
Root form titanium dental implant
Primary Outcome Measure Information:
Title
Integration Success of Implant
Description
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Cost Benefit Analysis
Description
In addition to clinical outcomes, the treatment groups will also be evaluated based on total cost of treatment. Because of differences in currencies and the manner in which materials and services are calculated, the resources needed will be quantified. "Resources" includes the variables of time, effort, and materials: "time" = how much time clinician devotes to the treatment of the case directly; also the time patients may lose from work or other duties while receiving treatment; Time includes the number of clinic visits, total chair time, and total clinician time. "Effort" is a subjective factor in terms of the type of procedure performed by the clinicians and by the need for patients to adjust to the discomforts of their treatment. "Materials" includes all devices employed, medications, and adjunctive services such as lab fees; includes interventions to treat complications or other unscheduled treatments.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano A Sanz, MD, DDS
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
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