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Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Primary Purpose

Dental Implant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Astra implants
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant focused on measuring HIV, Implant, Crown

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UAB Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HIV negative group

HIV positive group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 28, 2010
Last Updated
May 21, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT01211288
Brief Title
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Official Title
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Dentsply Sirona Implants and Consumables

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant
Keywords
HIV, Implant, Crown

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV negative group
Arm Type
Active Comparator
Arm Description
This group contains participants consented to receive implants and identified as negative for HIV
Arm Title
HIV positive group
Arm Type
Experimental
Arm Description
This group contains participants consented to receive implants and identified as positive for HIV
Intervention Type
Device
Intervention Name(s)
Astra implants
Intervention Description
Root form OsseoSpeed TX Astra Tech Implant System
Primary Outcome Measure Information:
Title
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Description
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.
Time Frame
Baseline to 12 months after implant restoration complete
Title
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Description
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.
Time Frame
Baseline to 24 months after implant restoration complete
Title
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Description
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.
Time Frame
Baseline to 36 months after implant restoration complete
Secondary Outcome Measure Information:
Title
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Description
Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.
Time Frame
12 months after implant restoration
Title
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Description
Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.
Time Frame
24 months after implant restoration
Title
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Description
Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs.
Time Frame
36 months after implant restoration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toni T Neumeier, DMD
Organizational Affiliation
UAB Dental School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Dental School
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined

Learn more about this trial

Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

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