Dental Implant
Conditions
Keywords
HIV, Implant, Crown
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAstra implants
Root form OsseoSpeed TX Astra Tech Implant System
Sponsors
Dentsply Sirona Implants and Consumables
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy enough to undergo the proposed therapy without compromise to existing health status * At least 19 years old * Able to read and understand written English without the aid of ad hoc interpretation * Able to cognitively understand the proposed study and therapy and possible prognoses * Able to consent for their own inclusion in the study. * Implant supported restorations are limited to the following edentulous areas: Mandibular arch (excluding 2nd and 3rd molar areas), Maxillary anterior and premolar areas
Exclusion criteria
* Smoker * Uncontrolled diabetes * Uncontrolled hypertension * Bisphosphonate user * Bruxer * Extraction site healed less than 6 months * Women pregnant or lactating at the time of enrollment * Previous malignant neoplasm * A known hypersensitivity to Titanium metal * Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing * Any indication of an inability to make autonomous decisions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | Baseline to 12 months after implant restoration complete | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 12 months after implant restoration | Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | HIV Negative Group | HIV Positive Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 20 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 11 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 9 Participants | 21 Participants |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 14 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
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.
Time frame: Baseline to 12 months after implant restoration complete
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Negative Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 28 implants |
| HIV Positive Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 25 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.
Time frame: Baseline to 24 months after implant restoration complete
Population: Unable to do follow up on 7 participants, three participants from HIV negative group and four participants from HIV positive group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Negative Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 27 implants |
| HIV Positive Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 20 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.
Time frame: Baseline to 36 months after implant restoration complete
Population: Unable to do follow up on 11 participants, five participants from HIV negative group and six participants from HIV positive group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Negative Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 25 implants |
| HIV Positive Group | Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects | 17 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.
Time frame: 24 months after implant restoration
Population: Unable to do follow up on 7 participants, three from HIV negative group and four from HIV positive group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV Negative Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.39 millmeters | Standard Deviation 0.49 |
| HIV Positive Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.33 millmeters | Standard Deviation 0.61 |
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.
Time frame: 36 months after implant restoration
Population: Unable to do follow up on 11 participants, five from HIV negative group and six from HIV positive group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV Negative Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.44 millmeters | Standard Deviation 0.52 |
| HIV Positive Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.48 millmeters | Standard Deviation 0.95 |
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.
Time frame: 12 months after implant restoration
Population: Unable to do follow up on three participants, two from HIV negative group and one from HIV positive group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV Negative Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.34 millmeters | Standard Deviation 0.58 |
| HIV Positive Group | Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects | 0.35 millmeters | Standard Deviation 0.71 |