Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
- Conditions
- Jaw, Edentulous, Partially
- Interventions
- Device: OsseoSpeed™ length 11 mmDevice: OsseoSpeed™ length 6 mm
- Registration Number
- NCT00545818
- Lead Sponsor
- Dentsply Sirona Implants and Consumables
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group-2, Implant length 11 mm OsseoSpeed™ length 11 mm Subjects treated with OsseoSpeed™ implant, length: 11 mm Group-1, Implant length 6 mm OsseoSpeed™ length 6 mm Subjects treated with OsseoSpeed™ implant, length: 6 mm
- Primary Outcome Measures
Name Time Method Radiological Assessments of Marginal Bone Level Alteration 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.
- Secondary Outcome Measures
Name Time Method Presence of Plaque Evaluated at the 5-year follow-up visit after loading. 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.Overall Implant Survival Evaluated 5 years after implant placement Overall implant survival, measured on implant level
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP Measured at the 5-year follow-up visit after loading Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD Evaluated at implant loading and at the 5-year follow-up visit. 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.
Trial Locations
- Locations (6)
USC School of Dentistry
🇺🇸Los Angeles, California, United States
School of Dental Science, University of Melbourne
🇦🇺Melbourne, Victoria, Australia
Dept. of Parodontology, Göteborg University
🇸🇪Göteborg, Sweden
Praktijk De Mondhoek
🇳🇱Apeldoorn, Netherlands
The University of Iowa, College of Dentistry
🇺🇸Iowa City, Iowa, United States
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
🇬🇧London, United Kingdom