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Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Not Applicable
Completed
Conditions
Dental Implant
Interventions
Device: Astra implants
Registration Number
NCT01211288
Lead Sponsor
University of Alabama at Birmingham
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HIV negative groupAstra implantsThis group contains participants consented to receive implants and identified as negative for HIV
HIV positive groupAstra implantsThis group contains participants consented to receive implants and identified as positive for HIV
Primary Outcome Measures
NameTimeMethod
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative SubjectsBaseline to 36 months after implant restoration complete

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.

Secondary Outcome Measures
NameTimeMethod
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects36 months after implant restoration

Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs.

Trial Locations

Locations (1)

UAB Dental School

🇺🇸

Birmingham, Alabama, United States

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