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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.
This study will review the osseointegration of implant supported restorations in HIV positive and HIV negative patients, then follow patients over a 3 year period of time. The treatment outcome as measured according to Mish criteria for implant success. Patients will be examined at each interval for the presence of pain, infection, mobility, and radiographic bone height of each implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV negative group | Active Comparator | This group contains participants consented to receive implants and identified as negative for HIV |
|
| HIV positive group | Experimental | This group contains participants consented to receive implants and identified as positive for HIV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astra implants | Device | Root form OsseoSpeed TX Astra Tech Implant System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental implant supported restorations functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Baseline to 12 months after implant restoration complete |
| Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental Implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Baseline to 24 months after implant restoration complete |
| Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Baseline to 36 months after implant restoration complete |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs. | 12 months after implant restoration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toni T Neumeier, DMD | UAB Dental School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Dental School | Birmingham | Alabama | 35294 | United States |
To be determined
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV Negative Group | This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System |
| FG001 | HIV Positive Group | This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV Negative Group | This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System |
| BG001 | HIV Positive Group |
| 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 | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental implant supported restorations functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Unable to do follow up on 3 participants - two participants from HIV negative group and one participant from HIV positive group, and one implant failure from HIV positive group | Posted | Number | implants | Baseline to 12 months after implant restoration complete | implants | implants |
|
The specific period for this study was over 8 years from the time the first subject selected until 3 years follow up completed.
Total 11 participants did not complete all follow up appointments through the end of the study. There are 5 in HIV negative group and 6 in HIV positive group.
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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 | HIV Negative Group | This group contains participants consented to receive implants and identified as negative for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System |
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Based on a survey given every year, participants were extremely satisfied with the outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Toni Tien Neumeier | University of Alabama at Birmingham | 205-934-5459 | neumeier@uab.edu |
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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 | Aug 30, 2019 | Apr 21, 2020 | Prot_SAP_000.pdf |
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| Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects |
Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs. |
| 24 months after implant restoration |
| Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs. | 36 months after implant restoration |
This group contains participants consented to receive implants and identified as positive for HIV
Astra implants: Root form OsseoSpeed TX Astra Tech Implant System
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System |
|
|
| Primary | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental Implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Unable to do follow up on 7 participants, three participants from HIV negative group and four participants from HIV positive group | Posted | Number | implants | Baseline to 24 months after implant restoration complete | implants | implants |
|
|
|
| Primary | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Dental implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site. | Unable to do follow up on 11 participants, five participants from HIV negative group and six participants from HIV positive group | Posted | Number | implants | Baseline to 36 months after implant restoration complete | implants | implants |
|
|
|
| Secondary | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs. | Unable to do follow up on three participants, two from HIV negative group and one from HIV positive group | Posted | Mean | Standard Deviation | millmeters | 12 months after implant restoration | implants | implants |
|
|
|
| Secondary | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs. | Unable to do follow up on 7 participants, three from HIV negative group and four from HIV positive group | Posted | Mean | Standard Deviation | millmeters | 24 months after implant restoration | implants | implants |
|
|
|
| Secondary | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs. | Unable to do follow up on 11 participants, five from HIV negative group and six from HIV positive group | Posted | Mean | Standard Deviation | millmeters | 36 months after implant restoration | implants | implants |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | HIV Positive Group | This group contains participants consented to receive implants and identified as positive for HIV Astra implants: Root form OsseoSpeed TX Astra Tech Implant System | 0 | 14 | 0 | 14 | 0 | 14 |
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