Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

NCT01211288 | Completed Results FDA Device

• 1 other identifier: F090730003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

HIV; Implant; Crown

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  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

  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

  36 months after implant restoration

Study Arms (2)

HIV negative group

ACTIVE COMPARATOR

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

Device: Astra implants

HIV positive group

EXPERIMENTAL

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

Device: Astra implants

Interventions

Astra implants DEVICE

Root form OsseoSpeed TX Astra Tech Implant System

HIV negative group; HIV positive group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Implant supported restorations are limited to the following edentulous areas: Mandibular arch (excluding 2nd and 3rd molar areas), Maxillary anterior and premolar areas

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

UAB Dental School

Birmingham, Alabama, 35294, United States

Location

Limitations and Caveats

Based on a survey given every year, participants were extremely satisfied with the outcome.

Results Point of Contact

• Title: Dr. Toni Tien Neumeier
• Organization: University of Alabama at Birmingham

neumeier@uab.edu

205-934-5459

Study Officials

• Toni T Neumeier, DMD

  UAB Dental School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2020
• Last Updated: June 2, 2020
• Results First Posted: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)