Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

The University of Alabama at Birmingham

Status: Completed

Conditions: Dental Implant

Treatments: Device: Astra implants

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01211288

F090730003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

HIV negative group

Active Comparator group

Description:

This group contains participants consented to receive implants and identified as negative for HIV

Treatment:

Device: Astra implants

HIV positive group

Experimental group

Description:

This group contains participants consented to receive implants and identified as positive for HIV

Treatment:

Device: Astra implants