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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental implant (Nanotite) | Active Comparator | Dental implants of short length placed without sinus lifts |
|
| Control group | No Intervention | Dental implants of standard length placed simultaneously with sinus augmentation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant (Nanotite) | Device | Root form titanium dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Integration Success of Implant | Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariano A Sanz, MD, DDS | Universidad Complutense de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Madrid | 28040 | Spain |
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Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began February 2009 and ended February 2011. All study patients were enrolled at 3 European Universities (dental clinics).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dental Implant (Nanotite) | Dental implants of short length placed without sinus lifts |
| FG001 | Control Group | Dental implants of standard length placed simultaneously with sinus augmentation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dental Implant (Nanotite) | Dental implants of short length placed without sinus lifts |
| BG001 | Control Group | Dental implants of standard length placed simultaneously with sinus augmentation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Integration Success of Implant | Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis. | Number of participants used in analysis selected as per protocol | Posted | Number | participants | 3 years | Dental implants | Dental implants |
|
Adverse events are collected and reported from day 1 of the study to present time (entire duration of study).
Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dental Implant (Nanotite) | Dental implants of short length placed without sinus lifts |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mobility | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment | Dental implant mobility as detected by visual assessment,radiography, and patient complaint (symptoms). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Biomet 3i LLC | 5617766722 | cristina.matthews@biomet.com |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Dental implants |
|
|
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | Control Group | Dental implants of standard length placed simultaneously with sinus augmentation | 0 | 20 | 5 | 20 |
|
PI shall furnish SPONSOR with a copy of any proposed publication thirty (30) days prior to submission for publication for review and comment. SPONSOR may request PI to delay publishing such proposed publication for a maximum of an additional sixty (60) days in order to protect the potential patentability of any invention described therein.
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |