Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Conditions
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Dental Implant

Intervention / Treatment
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* Device: Astra implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIV negative group<br>This group contains participants consented to receive implants and identified as negative for HIV | Device: Astra implants<br>* Root form OsseoSpeed TX Astra Tech Implant System<br>|
| Experimental: HIV positive group<br>This group contains participants consented to receive implants and identified as positive for HIV | Device: Astra implants<br>* Root form OsseoSpeed TX Astra Tech Implant System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Implant, Crown