Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
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.
1 other identifier
interventional
97
5 countries
6
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
May 19, 2020
CompletedMay 19, 2020
May 1, 2020
8.5 years
October 16, 2007
April 14, 2020
May 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Evaluated from implant installation to 5 years follow-up after implant placement
Secondary Outcomes (4)
Overall Implant Survival
Evaluated 5 years after implant placement
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Measured at the 5-year follow-up visit after loading
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Evaluated at implant loading and at the 5-year follow-up visit.
Presence of Plaque
Evaluated at the 5-year follow-up visit after loading.
Study Arms (2)
Group-1, Implant length 6 mm
EXPERIMENTALSubjects treated with OsseoSpeed™ implant, length: 6 mm
Group-2, Implant length 11 mm
OTHERSubjects treated with OsseoSpeed™ implant, length: 11 mm
Interventions
OsseoSpeed™ dental implant, length: 11 mm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
USC School of Dentistry
Los Angeles, California, 90089-0641, United States
The University of Iowa, College of Dentistry
Iowa City, Iowa, 52242-1010, United States
School of Dental Science, University of Melbourne
Melbourne, Victoria, 3010, Australia
Praktijk De Mondhoek
Apeldoorn, 7315, Netherlands
Dept. of Parodontology, Göteborg University
Gothenburg, SE 405 30, Sweden
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
London, SE1 9RT, United Kingdom
Related Publications (2)
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.
PMID: 22938573RESULTZadeh 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.
PMID: 30003598RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager Global Clinical Research
- Organization
- Dentsply Sirona Implants, Mölndal, SWEDEN
Study Officials
- STUDY DIRECTOR
Anna-Karin Lundgren
Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
November 1, 2007
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 19, 2020
Results First Posted
May 19, 2020
Record last verified: 2020-05