Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2020-05-01

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.

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV negative group

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

Group Type ACTIVE_COMPARATOR

Astra implants

Intervention Type DEVICE

Root form OsseoSpeed TX Astra Tech Implant System

HIV positive group

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

Group Type EXPERIMENTAL

Astra implants

Intervention Type DEVICE

Root form OsseoSpeed TX Astra Tech Implant System

Interventions

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Astra implants

Root form OsseoSpeed TX Astra Tech Implant System

Intervention Type DEVICE

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes