Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.
Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanotite implant | Experimental | Nanotite dental implant |
|
| Osseotite implant | Active Comparator | Osseotite dental implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanotite dental implant | Device | Nanotite root form titanium dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Integration Success of the Implant | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael S Reddy, DMD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Pre-treatment included a screening visit (enroll those meeting all protocol inclusion criteria), signing informed consent, and pre-surgical data collection. Patients returned for implant placement surgery, followed by restorative activities.
Up to 165 patients are expected to be enrolled across all centers, with enrollment efforts beginning in August 2008. Enrollment period remained opent until December 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nanotite Implant | Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant |
| FG001 | Osseotite Implant | Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Nanotite implants = 239 Osseotite implants = 246
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nanotite Implant | Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant |
| BG001 | Osseotite Implant | Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Overall number of Nanotite implants = 239 Overall number of Osseotite implants = 246 Nanotite implants in <18 yrs = 1 Nanotite implants in 18-65 = 163 Nanotite implants in >65 = 75 Osseotite implants in <18 yrs = 0 Osseotite implants in 18-65 = 173 Osseotite implants in >65 = 73 |
| 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 the Implant | Number of implants surviving (lack of mobility) at the end of the study (time of analysis) | Posted | Number | implants | 1 year | Implants | Implants |
|
|
Adverse events are collected and reported throughout the duration of the study, an average of 2 years.
Adverse event data is collected by patient questioning,visual examination, and radiologic assessment of patient's treatment area each study event visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nanotite Implant | Nanotite dental implant Nanotite dental implant : Nanotite root form titanium dental implant |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of integration of implant | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Biomet 3i LLC | 5617766722 | cristina.matthews@biomet.com |
Not provided
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
implant types were randomized- 2 different surface treatments
Not provided
Not provided
Not provided
Not provided
| Osseotite dental implant | Device | Osseotite Root form titanium dental implant |
|
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Overall number baseline implants Nanotite= 239 Overall number baseline implants Osseotite = 246 Nanotite implants in Females = 116 Nanotite implants in Males = 123 Osseotite implants in Females = 120 Osseotite implants in Males = 126 | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Implants |
|
|
| 0 |
| 122 |
| 9 |
| 122 |
| EG001 | Osseotite Implant | Osseotite dental implant Osseotite dental implant : Osseotite Root form titanium dental implant | 0 | 119 | 7 | 119 |
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.