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Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients

This study is currently recruiting participants.
Verified February 2012 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
Toni Neumeier, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01211288
First received: September 28, 2010
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose is to place implant in HIV positive and HIV negative patients, follow patients over 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients.


Condition
HIV Positive Patient Receive Implant Supported Restoration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients. [ Time Frame: Every 6 months after implant restoration complete ] [ Designated as safety issue: No ]
    To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients.


Secondary Outcome Measures:
  • Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs. [ Time Frame: one year after implant restoration ] [ Designated as safety issue: No ]
    Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs.

  • Histologic examination of bone biopsies from each implant surgical site, at the time of initial placement, and from failing implant sites, including histologic examination of the implant-bone interface. [ Time Frame: at the initial implant placement surgical site ] [ Designated as safety issue: No ]
    Histologic examination of bone biopsies from each implant surgical site, at the time of initial placement, and from failing implant sites, including histologic examination of the implant-bone interface.


Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
control group
Age 19 and older, Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer
HIV positive

HIV (+) patients with the following requirements:

Age 19 and older, Hemoglobin >8g/dl , Absolute neutrophil count >750/mm3, Platelet count>75,000cells/mm3, AST< 5 times the upper limit of normal (ULN), Bilirubin< 2.5 times ULN, Alkaline phosphate < 5 times ULN, Creatinine< 2.5 mg/ml Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer

Detailed Description:

The purpose is to place implant in HIV positive and HIV negative patients, follow patients over 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

In good general health with the following requirements:

Hemoglobin >8g/dl Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) Bilirubin< 2.5 times ULN Alkaline phosphate < 5 times ULN Creatinine< 2.5 mg/ml Non- smoker (quit smoking at least 6 months) Controlled - If type II diabetes Controlled - if hypertension Non bisphosphate user Non- bruxer Misch Available Bone classification divisions A, B, C Misch Bone Density classification D1, D2, D3 Minimal available bone width 5mm Minimal available bone height 10mm Minimum bone graft with freeze dried demineralised bone upon implant placement Extraction site has to be healed up for minimum 6 months before implant placement

Implant supported restorations are limited to the following edentulous areas:

Mandibular arches, excluding 3rd molar areas Maxillary anterior and premolar areas

Criteria

Inclusion Criteria:

  1. The existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
  2. Healthy enough to undergo the proposed therapy without compromise to existing health status
  3. At least 19 years old
  4. Able to read and understand written English without the aid of ad hoc interpretation
  5. Able to cognitively understand the proposed study and therapy and possible prognoses
  6. Able to consent for their own inclusion in the study.

Hemoglobin >8g/dl Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) Bilirubin< 2.5 times ULN Alkaline phosphate < 5 times ULN Creatinine< 2.5 mg/ml Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer Misch Available Bone classification divisions A, B, C Misch Bone Density classification D1, D2, D3 Minimal available bone width 5mm Minimal available bone height 10mm Minimum bone graft with freeze dried demineralised bone upon implant placement Extraction site has to be healed up for minimum 6 months before implant placement

Implant supported restorations are limited to the following edentulous areas:

Mandibular arches, excluding 3rd molar areas Maxillary anterior and premolar areas

Exclusion Criteria:

  1. Women who are pregnant or lactating at the time of enrollment
  2. Previous malignant neoplasm
  3. A known hypersensitivity to Titanium metal
  4. Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing
  5. Any indication of an inability to autonomous decisions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211288

Contacts
Contact: Toni T Neumeier, DMD 205-934-5459 neumeier@uab.edu
Contact: Perng-Ru Liu, DMD

Locations
United States, Alabama
UAB Dental School Recruiting
Birmingham, Alabama, United States, 35294
Contact: Toni T Neumeier, DMD     205-934-5459     neumeier@uab.edu    
Sub-Investigator: Perng-Ru Liu, DMD            
Sub-Investigator: Jeff Hill, DMD            
Sponsors and Collaborators
University of Alabama at Birmingham
Dentsply Implants
Investigators
Principal Investigator: Toni T Neumeier, DMD UAB Dental School
  More Information

No publications provided

Responsible Party: Toni Neumeier, Associate professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01211288     History of Changes
Other Study ID Numbers: F090730003
Study First Received: September 28, 2010
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
HIV
Implant
CBCT

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013