Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
This trial is active, not recruiting.
|Condition||osseointegration failure of dental implant from complication of systemic disease|
|Sponsor||University of Alabama at Birmingham|
|Start date||May 2010|
|End date||December 2017|
|Trial size||40 participants|
|Trial identifier||NCT01211288, F090730003|
The purpose is to place implants in HIV positive and HIV negative patients, follow patients over 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients.
|Observational model||case control|
To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients.
time frame: Every 6 months after implant restoration complete
Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs.
time frame: one year after implant restoration
Histologic examination of bone biopsies from each implant surgical site, at the time of initial placement, and from failing implant sites, including histologic examination of the implant-bone interface.
time frame: at the initial implant placement surgical site
Male or female participants from 19 years up to 80 years old.
Inclusion Criteria: 1. The existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction 2. Healthy enough to undergo the proposed therapy without compromise to existing health status 3. At least 19 years old 4. Able to read and understand written English without the aid of ad hoc interpretation 5. Able to cognitively understand the proposed study and therapy and possible prognoses 6. Able to consent for their own inclusion in the study. Hemoglobin >8g/dl Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) Bilirubin< 2.5 times ULN Alkaline phosphate < 5 times ULN Creatinine< 2.5 mg/ml Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer Misch Available Bone classification divisions A, B, C Misch Bone Density classification D1, D2, D3 Minimal available bone width 5mm Minimal available bone height 10mm Minimum bone graft with freeze dried demineralised bone upon implant placement Extraction site has to be healed up for minimum 6 months before implant placement Implant supported restorations are limited to the following edentulous areas: Mandibular arches, excluding 3rd molar areas Maxillary anterior and premolar areas Exclusion Criteria: 1. Women who are pregnant or lactating at the time of enrollment 2. Previous malignant neoplasm 3. A known hypersensitivity to Titanium metal 4. Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing 5. Any indication of an inability to autonomous decisions
|Official title||Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients|
|Principal investigator||Toni T Neumeier, DMD|
|Description||The purpose is to place implants and restore them with crowns in both HIV positive and HIV negative patients then follow patients 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients.|
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