Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients - Full Text View

Purpose

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
Osseointegration Failure of Dental Implant From Complication of Systemic Disease


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:	December 2017
Estimated Primary Completion Date:	December 2017 (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

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 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.

Eligibility


Ages Eligible for Study:	19 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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:

The existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
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.

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:

Women who are 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 autonomous decisions

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	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:	July 13, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:


HIV Implant Crown

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 September 29, 2016