Overview

This trial is active, not recruiting.

Condition osseointegration failure of dental implant from complication of systemic disease
Sponsor University of Alabama at Birmingham
Collaborator Dentsply Implants
Start date May 2010
End date December 2017
Trial size 40 participants
Trial identifier NCT01211288, F090730003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Age 19 and older, Non- smoker (quite smoking at least 6 months) Controlled Type II diabetes Controlled hypertension Non bisphosphate user Non- bruxer
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

Primary Outcomes

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

Secondary Outcomes

Measure
Radiographic examination of implant osseous integration using Cone Beam CT and traditional vertical bitewing radiographs.
time frame: one year after implant restoration
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

Eligibility Criteria

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Official title Longitudinal Study of Dental Implant Therapy in HIV- Positive Patients
Principal investigator Toni T Neumeier, DMD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.