Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
This study is ongoing, but not recruiting participants.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00545818
First received: October 16, 2007
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Radiological assessments of marginal bone level alteration [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Implant survival (on implant and patient level) Condition of periimplant mucosa Overall safety [ Time Frame: On a regular basis during 5 years follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: OsseoSpeed™
OsseoSpeed™ implant, length: 6 mm
|
| Active Comparator: 2 |
Device: OsseoSpeed™
OsseoSpeed™ implant, length: 11 mm
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545818
Locations
| United States, California | |
| USC School of Dentistry | |
| Los Angeles, California, United States, 90089-0641 | |
| United States, Iowa | |
| The University of Iowa, College of Dentistry | |
| Iowa City, Iowa, United States, 52242-1010 | |
| Australia, Victoria | |
| School of Dental Science, University of Melbourne | |
| Melbourne, Victoria, Australia, 3010 | |
| Netherlands | |
| Praktijk De Mondhoek | |
| Apeldoorn, Netherlands, 7315 | |
| Sweden | |
| Dept. of Parodontology, Göteborg University | |
| Göteborg, Sweden, SE 405 30 | |
| United Kingdom | |
| King's College London Dental Institute at Guy's King's and St Thomas' Hospitals | |
| London, United Kingdom, SE1 9RT | |
Sponsors and Collaborators
Dentsply Implants
More Information
No publications provided
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT00545818 History of Changes |
| Other Study ID Numbers: | YA-SHO-0001 |
| Study First Received: | October 16, 2007 |
| Last Updated: | March 14, 2013 |
| Health Authority: | Australia: National Health and Medical Research Council The Netherlands: Independent Review Board, Nijmegen Sweden: Regional Ethical Review Board, Göteborg United States: Institutional Review Board United Kingdom: Guy's & St Thomas' NHS Foundation Trust |
Additional relevant MeSH terms:
|
Jaw, Edentulous Jaw, Edentulous, Partially Mouth, Edentulous Jaw Diseases |
Musculoskeletal Diseases Stomatognathic Diseases Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on May 16, 2013