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Change in crestal bone level implants at 5% significance level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankylos dental implants. | Experimental | 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis. |
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| 3i Prevail dental implants. | Active Comparator | Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankylos Implants | Device | ANKYLOS Implant System vs Certain PREVAIL Implant |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 6 months after surgery |
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 12 months after surgery |
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Romanos, DDS | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester, Eastman Dept of Dentistry | Rochester | New York | 14620 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dental Implants. | 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study. A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Biomet 3i Prevail Implants |
| Device |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dental Implants. | 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study. A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis. After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | Posted | Number | Percentage of implants | 6 months after surgery | Implants | Participants |
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| Primary | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | Posted | Number | Percentage of implants | 12 months after surgery | Implants | Participants |
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| Primary | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. | Posted | Number | Percentage of implants | 24 months after surgery | Implants | Participants |
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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 Implants. | 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration. Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study. | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Romanos | University if Rochester Medical Center | 585-276-4149 | GeorgiosRomanos@urmc.rochester.edu |
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