Clinical trial NCT01211288: Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Official title: Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: HIV
Implant
Crown
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2010-09-29
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.

Detailed description: This study will review the osseointegration of implant supported restorations in HIV positive and HIV negative patients, then follow patients over a 3 year period of time. The treatment outcome as measured according to Mish criteria for implant success. Patients will be examined at each interval for the presence of pain, infection, mobility, and radiographic bone height of each implant.

Eligibility criteria: Inclusion Criteria:

* 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.
* Implant supported restorations are limited to the following edentulous areas: Mandibular arch (excluding 2nd and 3rd molar areas), Maxillary anterior and premolar areas

Exclusion Criteria:

* Smoker
* Uncontrolled diabetes
* Uncontrolled hypertension
* Bisphosphonate user
* Bruxer
* Extraction site healed less than 6 months
* Women 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 make autonomous decisions

Primary outcomes:
measure: Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: Baseline to 12 months after implant restoration complete
measure: Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: Baseline to 24 months after implant restoration complete
measure: Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: Baseline to 36 months after implant restoration complete
Secondary outcomes:
measure: Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: 12 months after implant restoration
measure: Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: 24 months after implant restoration
measure: Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
timeFrame: 36 months after implant restoration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Dental School
state: Alabama
Study officials:
affiliation: UAB Dental School
name: Toni T Neumeier, DMD
role: PRINCIPAL_INVESTIGATOR
References: