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This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.
All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3 with DCD tapered Prevail implant | Experimental | T3 with DCD tapered prevail implant |
|
| Nanotite certain tapered implant | Active Comparator | Nanotite Certain tapered implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3 with DCD tapered Prevail implant | Device | T3 with DCD implant with Certain (internal) connection and platform-switch design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Success Rate | Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone Changes | Crestal bone regression (amount of bone loss) between the two treatment groups will be compared | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Lewis, DMD | Eastman Dental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Tommie VanDeVelde | Antwerp | Belgium | ||||
| Dr. Dominique Caspar |
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| ID | Title | Description |
|---|---|---|
| FG000 | T3 With DCD Tapered Prevail Implant | T3 with DCD tapered prevail implant |
| FG001 | Nanotite Certain Tapered Implant | Nanotite Certain tapered implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T3 With DCD Tapered Implant | T3 with DCD tapered prevail implant |
| BG001 | Nanotite Certain Tapered Implant | Nanotite Certain tapered implant |
| 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 | Cumulative Success Rate | Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles. | Posted | Number | implants | 1 year | implants | implants |
|
|
from enrollment until the end of 5 year follow up
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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 | T3 With DCD Tapered Prevail Implant | T3 with DCD tapered prevail implant | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| implant failure | Surgical and medical procedures | Systematic Assessment | mobility, loss of integration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Matthews | ZimVie | 5613084390 | cristina.matthews@zimvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2013 | Apr 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Nanotite Certain tapered implant | Device | Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design |
|
|
| Les Bains |
| France |
| Dr. Felix Hanssler | Göppingen | Germany |
| Dr. Nicholas Lewis | London | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| implants |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Participants |
|
| implants |
|
|
| Secondary | Crestal Bone Changes | Crestal bone regression (amount of bone loss) between the two treatment groups will be compared | Posted | Mean | Standard Deviation | millimeters | 2 years | implants | implants |
|
|
|
| 32 |
| 0 |
| 32 |
| 6 |
| 32 |
| EG001 | Nanotite Certain Tapered Implant | Nanotite Certain tapered implant | 0 | 8 | 0 | 8 | 4 | 8 |
|
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