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Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients

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ClinicalTrials.gov Identifier: NCT01211288
Recruitment Status : Active, not recruiting
First Posted : September 29, 2010
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Toni Neumeier, University of Alabama at Birmingham

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Peri-Implantitis

Detailed Description:
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.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
Actual Study Start Date : May 2010
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    To study the short term and long term osseous integration of implant supported restorations on immunocompromised (HIV positive) patients.


Secondary Outcome Measures :
  1. Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs. [ Time Frame: one year after implant restoration ]
    Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs.

  2. 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 ]
    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.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211288


Locations
United States, Alabama
UAB Dental School
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Dentsply Sirona Implants
Investigators
Principal Investigator: Toni T Neumeier, DMD UAB Dental School
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Toni Neumeier, Associate professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01211288     History of Changes
Other Study ID Numbers: F090730003
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Toni Neumeier, University of Alabama at Birmingham:
HIV
Implant
Crown

Additional relevant MeSH terms:
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases