Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Dental Implant Clinical Trial

Official title:

Longitudinal Study of Dental Implant Therapy in HIV Positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211288
• Other study ID #: F090730003
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant
• HIV Seropositivity

Intervention

Device:
• Astra implants
Root form OsseoSpeed TX Astra Tech Implant System

Locations

Country	Name	City	State
United States	UAB Dental School	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Dentsply Sirona Implants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	Dental implant supported restorations functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.	Baseline to 12 months after implant restoration complete
Primary	Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	Dental Implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.	Baseline to 24 months after implant restoration complete
Primary	Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects	Dental implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.	Baseline to 36 months after implant restoration complete
Secondary	Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.	12 months after implant restoration
Secondary	Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	Radiographic examination of implant osseointegration and bone loss by using traditional periapical and/or bitewing radiographs.	24 months after implant restoration
Secondary	Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects	Radiographic examination of implant osseointegration and bone loss by using traditional periapical and /or bitewing radiographs.	36 months after implant restoration