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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
OsseoSpeed™ dental implant, length: 6 mm
OsseoSpeed™ dental implant, length: 11 mm
USC School of Dentistry
Los Angeles, California, United States
The University of Iowa, College of Dentistry
Iowa City, Iowa, United States
School of Dental Science, University of Melbourne
Melbourne, Victoria, Australia
Praktijk De Mondhoek
Apeldoorn, Netherlands
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.
Time frame: Evaluated from implant installation to 5 years follow-up after implant placement
Overall Implant Survival
Overall implant survival, measured on implant level
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Dept. of Parodontology, Göteborg University
Gothenburg, Sweden
King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
London, United Kingdom
Time frame: Evaluated at the 5-year follow-up visit after loading.