Dental ImplantNCT01211288
Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
A study testing Astra implants in people with Dental Implant, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Astra implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 1 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoker
- Uncontrolled diabetes
- Uncontrolled hypertension
- Bisphosphonate user
- Bruxer
- Extraction site healed less than 6 months
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dental Implant
- Being tested
- Astra implants
- Keywords
- HIV, Implant, Crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astra implantsDevice
Root form OsseoSpeed TX Astra Tech Implant System
| Study group | Role | What they receive |
|---|---|---|
| HIV negative group | Active comparator | This group contains participants consented to receive implants and identified as negative for HIV Receives: Device: Astra implants |
| HIV positive group | Experimental | This group contains participants consented to receive implants and identified as positive for HIV Receives: Device: Astra implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months after implant restoration complete
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.
Measured: Baseline to 24 months after implant restoration complete
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.
Measured: Baseline to 36 months after implant restoration complete
Secondary outcomes (3)
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.
Measured: 12 months after implant restoration
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.
Measured: 24 months after implant restoration
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.
Measured: 36 months after implant restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startMay 2010
- Primary completion1 Apr 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Toni Neumeier, University of Alabama at Birmingham
- Investigators
- Toni T Neumeier, DMD, Principal investigator, UAB Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211288
- Sponsor's protocol ID
- F090730003
- Status last verified
- May 2020
- First submitted
- 28 Sep 2010
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
- ClinicalTrials.gov ID
- NCT01211288
- Acronym / sponsor ID
- F090730003
- Conditions
- Dental Implant
- Keywords
- HIV, Implant, Crown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- May 2010 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Posted 15 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV negative group | Active comparator | Device: Astra implantsThis group contains participants consented to receive implants and identified as negative for HIV |
| HIV positive group | Experimental | Device: Astra implantsThis group contains participants consented to receive implants and identified as positive for HIV |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Smoker
- Uncontrolled diabetes
- Uncontrolled hypertension
- Bisphosphonate user
- Bruxer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astra implantsRoot form OsseoSpeed TX Astra Tech Implant System | Device | HIV negative group, HIV positive group |
Primary outcome
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: Baseline to 12 months after implant restoration complete
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.
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: Baseline to 24 months after implant restoration complete
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.
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: Baseline to 36 months after implant restoration complete
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.
3 secondary outcomes
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: 12 months after implant restoration
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: 24 months after implant restoration
Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects
Time frame: 36 months after implant restoration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni T Neumeier, DMD principal investigator
UAB Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astra implants in people with Dental Implant, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects (time frame: Baseline to 12 months after implant restoration complete). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.