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NCT Number: NCT01211288

Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

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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Key information

Conditions

Dental Implant

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Dental School

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astra implants

Device

Root form OsseoSpeed TX Astra Tech Implant System

Primary outcomes

  1. Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects

    Time frame: Baseline to 12 months after implant restoration complete

    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.

  2. Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects

    Time frame: Baseline to 24 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.

  3. Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects

    Time frame: Baseline 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 outcomes

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

    Time frame: 12 months after implant restoration

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

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

    Time frame: 24 months after implant restoration

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

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

    Time frame: 36 months after implant restoration

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Important dates

Study start
2010
Primary completion
2019
Study completion
2020
First posted
Sep 29, 2010
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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