Partial Edentulism in the Maxilla or in the MandibleNCT01528215
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
A study testing OsseoSpeed EV and OsseoSpeed TX in people with Partial Edentulism in the Maxilla or in the Mandible, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Partial Edentulism in the Maxilla or in the Mandible
- What is being tested?
- OsseoSpeed EV and OsseoSpeed TX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Nov 2011to Apr 2018
- 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 Informed Consent.
- 18 -75 years at enrollment.
- In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
- History of edentulism in the planned implant area of at least 3 months (at Visit 2).
- At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
- Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
- Deemed by the investigator to be suitable for loading after 6-8 weeks.
- Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator.
- Uncontrolled pathological processes in the oral cavity.
- Untreated, uncontrolled caries and/or periodontal disease.
- Known or suspected current malignancy.
- History of radiation therapy in the head and neck region.
- History of chemotherapy within 5 years prior to surgery.
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- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
- Uncontrolled diabetes mellitus.
- Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
- Smoking more than 10 cigarettes per day.
- Present alcohol and/or drug abuse.
- Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
- Previous enrollment in the present study.
- Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
Dows Institute for Dental Research, University of Iowa, College of Dentistry
Iowa City, Iowa, 52242-1010
Belgium1 site
University Hospital Ghent, Dental School Department Periodontology
Ghent, 9000
Germany1 site
Dep. of Prosthodontics, Goethe University
Frankfurt am Main, 605 90
About this study
Official title: An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.
The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
- Being tested
- OsseoSpeed EV, OsseoSpeed TX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed EVDevice
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
OsseoSpeed TXDevice
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
| Study group | Role | What they receive |
|---|---|---|
| OsseoSpeed EV | Experimental | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm Receives: Device: OsseoSpeed EV |
| OsseoSpeed TX | Active comparator | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm Receives: Device: OsseoSpeed TX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Change After 1 Year in Use.
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
Measured: Evaluated at implant loading and at the 1 year follow-up after implant loading.
Secondary outcomes (1)
Marginal Bone Level Change After 5 Years in Use.
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Measured: Evaluated from implant loading to the 5 years follow-up after implant loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionApr 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Edentulism in the Maxilla or in the MandibleStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clark M Stanford, Prof, Principal investigator, University of Illinois at Chicago, College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528215
- Sponsor's protocol ID
- OTX-PLUS-0001
- Status last verified
- Apr 2020
- First submitted
- 3 Feb 2012
- Last updated
- 22 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869.
PubMed 27447160
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.
- ClinicalTrials.gov ID
- NCT01528215
- Acronym / sponsor ID
- OTX-PLUS-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Posted 14 Apr 2016
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 evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsseoSpeed EV | Experimental | Device: OsseoSpeed EVOsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| OsseoSpeed TX | Active comparator | Device: OsseoSpeed TXOsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of Informed Consent.
- 18 -75 years at enrollment.
- In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
- History of edentulism in the planned implant area of at least 3 months (at Visit 2).
- At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
Key exclusion criteria (15 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator.
- Uncontrolled pathological processes in the oral cavity.
- Untreated, uncontrolled caries and/or periodontal disease.
- Known or suspected current malignancy.
- History of radiation therapy in the head and neck region.
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 |
|---|---|---|
| OsseoSpeed EVOsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm | Device | OsseoSpeed EV |
| OsseoSpeed TXOsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm | Device | OsseoSpeed TX |
Primary outcome
Marginal Bone Level Change After 1 Year in Use.
Time frame: Evaluated at implant loading and at the 1 year follow-up after implant loading.
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
1 secondary outcome
Marginal Bone Level Change After 5 Years in Use.
Time frame: Evaluated from implant loading to the 5 years follow-up after implant loading.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27447160Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869.
Related trials for Partial Edentulism in the Maxilla or in the Mandible
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Comparing 7 mm and 5 mm Implants Placed Immediately After Molar Extraction
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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.
Clark M Stanford, Prof principal investigator
University of Illinois at Chicago, College of Dentistry
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed EV and OsseoSpeed TX in people with Partial Edentulism in the Maxilla or in the Mandible, run by Dentsply Sirona Implants and Consumables at 4 sites in 4 countries.
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 8 inclusion and 15 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium, Germany, Italy. 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 14 Apr 2016). 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 Change After 1 Year in Use. (time frame: Evaluated at implant loading and at the 1 year follow-up after implant loading.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528215, which also lists 1 linked publication.
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 22 Apr 2020.