Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

University of Alabama at Birmingham41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Implant

Interventions

Astra implantsDEVICE

Root form OsseoSpeed TX Astra Tech Implant System

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UAB Dental School

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects

Data from ClinicalTrials.gov

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