Jaw, Edentulous, PartiallyNCT00545818
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
A study testing OsseoSpeed™ length 6 mm and OsseoSpeed™ length 11 mm in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 6 sites in 5 countries.
Trial summary
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- OsseoSpeed™ length 6 mm and OsseoSpeed™ length 11 mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Nov 2007to May 2016
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
- Deemed by the investigator as likely to present an initially stable implant situation
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
Show all 15Show fewer
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
The University of Iowa, College of Dentistry
Iowa City, Iowa, 52242-1010
USC School of Dentistry
Los Angeles, California, 90089-0641
Australia1 site
School of Dental Science, University of Melbourne
Melbourne, Victoria, 3010
United Kingdom1 site
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
London, SE1 9RT
About this study
Official title: An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- OsseoSpeed™ length 6 mm, OsseoSpeed™ length 11 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.
OsseoSpeed™ length 6 mmDevice
OsseoSpeed™ dental implant, length: 6 mm
OsseoSpeed™ length 11 mmDevice
OsseoSpeed™ dental implant, length: 11 mm
| Study group | Role | What they receive |
|---|---|---|
| Group-1, Implant length 6 mm | Experimental | Subjects treated with OsseoSpeed™ implant, length: 6 mm Receives: Device: OsseoSpeed™ length 6 mm |
| Group-2, Implant length 11 mm | Other | Subjects treated with OsseoSpeed™ implant, length: 11 mm Receives: Device: OsseoSpeed™ length 11 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Assessments of Marginal Bone Level Alteration
Marginal Bone Level determined from radiographs and expressed as the difference 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 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).
Positive value = bone gain, Negative value = bone loss.
Measured: Evaluated from implant installation to 5 years follow-up after implant placement
Secondary outcomes (4)
Overall Implant Survival
Overall implant survival, measured on implant level
Measured: Evaluated 5 years after implant placement
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.
Measured: Measured at the 5-year follow-up visit after loading
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD).
Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).
Negative value = increased pocket depth.
Measured: Evaluated at implant loading and at the 5-year follow-up visit.
Presence of Plaque
Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.
A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.
Measured: Evaluated at the 5-year follow-up visit after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2016
- Study completionMay 2016
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 (2)Papers the sponsor has linked to this study.
- 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna-Karin Lundgren, Study director, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545818
- Sponsor's protocol ID
- YA-SHO-0001
- Status last verified
- May 2020
- First submitted
- 16 Oct 2007
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
PubMed 22938573Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
PubMed 30003598
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
- ClinicalTrials.gov ID
- NCT00545818
- Acronym / sponsor ID
- YA-SHO-0001
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 19 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 of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1, Implant length 6 mm | Experimental | Device: OsseoSpeed™ length 6 mmSubjects treated with OsseoSpeed™ implant, length: 6 mm |
| Group-2, Implant length 11 mm | Other | Device: OsseoSpeed™ length 11 mmSubjects treated with OsseoSpeed™ implant, length: 11 mm |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
Key exclusion criteria (15 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- 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™ length 6 mmOsseoSpeed™ dental implant, length: 6 mm | Device | Group-1, Implant length 6 mm |
| OsseoSpeed™ length 11 mmOsseoSpeed™ dental implant, length: 11 mm | Device | Group-2, Implant length 11 mm |
Primary outcome
Radiological Assessments of Marginal Bone Level Alteration
Time frame: Evaluated from implant installation to 5 years follow-up after implant placement
Marginal Bone Level determined from radiographs and expressed as the difference 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 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
4 secondary outcomes
Overall Implant Survival
Time frame: Evaluated 5 years after implant placement
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Time frame: Measured at the 5-year follow-up visit after loading
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Time frame: Evaluated at implant loading and at the 5-year follow-up visit.
Presence of Plaque
Time frame: Evaluated at the 5-year follow-up visit after loading.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22938573Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
- Results publication: PubMed 30003598Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
Related trials for Jaw, Edentulous, Partially
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Active, not recruiting
Osseodensification for Narrow Alveolar Ridge Expansion
Osseodensification, Bone Expansion
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.
Anna-Karin Lundgren study director
Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed™ length 6 mm and OsseoSpeed™ length 11 mm in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 6 sites in 5 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 7 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Netherlands, Sweden, United Kingdom. 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 19 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?
Radiological Assessments of Marginal Bone Level Alteration (time frame: Evaluated from implant installation to 5 years follow-up after implant placement). 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 NCT00545818, which also lists 2 linked publications.
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 19 May 2020.