Jaw, Edentulous, PartiallyNCT00748241
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
A study testing Astra Tech Fixture ST in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 2 sites in United States.
Trial summary
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Astra Tech Fixture ST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2000to Aug 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75
- Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
- Willing to give informed consent
Who cannot join
- Bone height < 5 mm, in the planned implant area
- Bone width < 5 mm, in the planned implant area
- Previous bone augmentation procedure in the planned implant area
- Previous failures of endosseous implants
- Untreated caries and/or periodontal disease of residual dentition
- History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Show all 9Show fewer
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Current alcohol or drug abuse
- Unable or unwilling to return for follow-up visits for 3 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
New York, New York, 10010
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center
New York, New York, 10010
About this study
Official title: An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Astra Tech Fixture ST
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astra Tech Fixture STDevice
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
| Study group | Role | What they receive |
|---|---|---|
| Astra Tech Fixture ST | Experimental | Not described Receives: Device: Astra Tech Fixture ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Measured: At follow-up visit: 6 months after implants have been loaded
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Measured: At follow-up visit: 1 year after implants have been loaded
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Measured: At follow-up visit: 2 years after implants have been loaded
Implant Survival Rate
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Measured: At follow-up visit: 3 years after implants have been loaded
Secondary outcomes (1)
Implant Failure
Total number of implants reported as failure.
Measured: 3 years after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startSep 2000
- Primary completionAug 2008
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 Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce G Valauri, D.D.S., Principal investigator, New York Dept of Veterans Affairs Medical CenterMichael Toffler, D.D.S., Principal investigator, New York Dept of Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748241
- Sponsor's protocol ID
- YA-MIC-0002
- Status last verified
- Jan 2012
- First submitted
- 5 Sep 2008
- Last updated
- 15 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.
- ClinicalTrials.gov ID
- NCT00748241
- Acronym / sponsor ID
- YA-MIC-0002
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Aug 2008 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 15 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Astra Tech Fixture ST | Experimental | Device: Astra Tech Fixture ST |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 75
- Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
- Willing to give informed consent
Key exclusion criteria (9 listed)
- Bone height < 5 mm, in the planned implant area
- Bone width < 5 mm, in the planned implant area
- Previous bone augmentation procedure in the planned implant area
- Previous failures of endosseous implants
- Untreated caries and/or periodontal disease of residual dentition
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 Tech Fixture STAstra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm. | Device | Astra Tech Fixture ST |
Primary outcome
Implant Survival Rate
Time frame: At follow-up visit: 6 months after implants have been loaded
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Implant Survival Rate
Time frame: At follow-up visit: 1 year after implants have been loaded
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Implant Survival Rate
Time frame: At follow-up visit: 2 years after implants have been loaded
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Implant Survival Rate
Time frame: At follow-up visit: 3 years after implants have been loaded
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
1 secondary outcome
Implant Failure
Time frame: 3 years after implant placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bruce G Valauri, D.D.S. principal investigator
New York Dept of Veterans Affairs Medical Center
Michael Toffler, D.D.S. principal investigator
New York Dept of Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astra Tech Fixture ST in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 2 sites 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 3 inclusion and 9 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Feb 2012). 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?
Implant Survival Rate (time frame: At follow-up visit: 6 months after implants have been loaded). The study lists 4 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 15 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.