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Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01211288
First received: September 28, 2010
Last updated: July 13, 2016
Last verified: June 2016

September 28, 2010
July 13, 2016
May 2010
December 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01211288 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
The purpose is to place implants 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.
The purpose is to place implants and restore them with crowns in both HIV positive and HIV negative patients then follow patients 3 years period of time, to evaluate how well dental implants perform in HIV-positive patients versus HIV-negative patients.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

In good general health with the following requirements:

Absolute neutrophil count >750/mm3 Platelet count>75,000cells/mm3 AST< 5 times the upper limit of normal (ULN) 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 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

Osseointegration Failure of Dental Implant From Complication of Systemic Disease
Not Provided
  • 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

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01211288
F090730003
No
Not Provided
Not Provided
University of Alabama at Birmingham
University of Alabama at Birmingham
Dentsply Sirona Implants
Principal Investigator: Toni T Neumeier, DMD UAB Dental School
University of Alabama at Birmingham
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP