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.

Study Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Device: Astra implants

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIV negative group; This group contains participants consented to receive implants and identified as negative for HIV	Device: Astra implants; Root form OsseoSpeed TX Astra Tech Implant System
Experimental: HIV positive group; This group contains participants consented to receive implants and identified as positive for HIV	Device: Astra implants; Root form OsseoSpeed TX Astra Tech Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to 36 months after implant restoration complete

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs.	36 months after implant restoration

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Toni T Neumeier, DMD, UAB Dental School

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Implant; Crown
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: F090730003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No