Jaw, Edentulous, PartiallyNCT00746187
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
A study testing ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. and 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm 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 to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. 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 Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. and 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2002to Jun 2011
- 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
- Provision of written informed consent
- Age 18 - 75 years
- Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- Edentulous in the area/s if implant placement for more than 2 months
Who cannot join
- Untreated caries and/or periodontal disease of residual dentition
- Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- Absence of occlusal stability in centric occlusion
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Pregnancy
Show all 9Show fewer
- Present alcohol or drug abuse
- Tobacco smoking during the last 6 months
- Unable or unwilling to return for follow-up visits for a period of 3 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dept. of Prosthodontics, School of Dentistry, University of North Carolina
Chapel Hill, North Carolina, 27599-7450
Dept. of Implant Dentistry, New York University
New York, New York, 10010
About this study
Official title: An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm., 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
- 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 Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.Device
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mmDevice
| Study group | Role | What they receive |
|---|---|---|
| ASTRA TECH Implant System; Fixture ST | Experimental | Ø 4.5 cm in lengths 9-13 mm Receives: Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. |
| Biomet 3i; Osseotite® Implants | Experimental | Ø 4.0 cm in lengths 8.5-13 mm Receives: Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Changes
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
Measured: 3 years after implant placement (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startDec 2002
- Primary completionJun 2011
- Study completionJun 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis P Tarnow, D.D.S. Prof., Principal investigator, Dept. of Implant Dentistry, New York University (to March 2011)Stuart Froum, Dr, Principal investigator, Dept. of Implant Dentistry, New York University (from March 2011)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746187
- Sponsor's protocol ID
- YA-MIC-0003
- Status last verified
- Mar 2016
- First submitted
- 2 Sep 2008
- Last updated
- 13 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
- ClinicalTrials.gov ID
- NCT00746187
- Acronym / sponsor ID
- YA-MIC-0003
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 16 Apr 2014
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 to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASTRA TECH Implant System; Fixture ST | Experimental | Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.Ø 4.5 cm in lengths 9-13 mm |
| Biomet 3i; Osseotite® Implants | Experimental | Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mmØ 4.0 cm in lengths 8.5-13 mm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent
- Age 18 - 75 years
- Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- Edentulous in the area/s if implant placement for more than 2 months
Key exclusion criteria (9 listed)
- Untreated caries and/or periodontal disease of residual dentition
- Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- Absence of occlusal stability in centric occlusion
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
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 Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. | Device | ASTRA TECH Implant System; Fixture ST |
| 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm | Device | Biomet 3i; Osseotite® Implants |
Primary outcome
Marginal Bone Level Changes
Time frame: 3 years after implant placement (baseline)
Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- 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.
Dennis P Tarnow, D.D.S. Prof. principal investigator
Dept. of Implant Dentistry, New York University (to March 2011)
Stuart Froum, Dr principal investigator
Dept. of Implant Dentistry, New York University (from March 2011)
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 Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm. and 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm 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 4 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 13 Apr 2016. 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 16 Apr 2014). 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?
Marginal Bone Level Changes (time frame: 3 years after implant placement (baseline)). 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 13 Apr 2016.