N/A
N=41
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Dental Implant
Bottom Line
View on ClinicalTrials.gov: NCT01211288 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects — 28; 25 implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Astra implants (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects |
25; 17 | — |
| PRIMARY Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects |
25; 17 | — |
| PRIMARY Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects |
25; 17 | — |
| SECONDARY Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects |
0.44; 0.48 | — |
| SECONDARY Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects |
0.44; 0.48 | — |
| SECONDARY Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects |
0.44; 0.48 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01211288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.