The primary objective of this study is to demonstrate non-inferiority of the Straumann Bone Level Ø 3.3 mm NC SLActive Roxolid Implants compared to Straumann Bone Level Ø 4.1 mm RC SLActive Roxolid Implants based on mean crestal bone level changes measured between surgery and 12 months post-implant placement. The secondary objectives will assess differences in clinical outcomes between the test and control implants, including implant success and survival, gingival recession, subject satisfaction and additional early bone level measurements.
This is a randomized, controlled, multi-center clinical study. The total study duration for each patient should be 12 ± 1 months. Straumann Bone Level implants will be placed in the pre-molar or anterior region of the mandible or maxilla for single tooth replacement, followed by provisional prosthetic loading after 25 ± 4 days and by final prosthetic loading 6 ± 1 months after implant loading. In total 6 visits per patient are scheduled in this study. Bone level changes, implant success and survival, gingival recession, subject satisfaction and adverse events (AEs) will be assessed. The study devices are CE-(Conformité Européenne, meaning European Conformity) marked products. Straumann Bone Level implants Ø 3.3 mm NC SLActive Roxolid and Straumann Bone Level Ø 4.1 mm RC SLActive implants. Five centers in USA will participate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Straumann Bone Level Implants, 4.1 mm implant diameter
Straumann Bone Level Implants, 3.3 mm implant diameter
UCLA School of Dentistry
Los Angeles, California, United States
Boston University, School of Dental Medicine
Boston, Massachusetts, United States
New York University College of Dentistry
New York, New York, United States
Univeristy of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Mean Crestal Bone Level Change
Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.
Time frame: Baseline (implant placement) and 12 months post loading
Additional Mean Crestal Bone Level Changes
Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading
Time frame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading
Implant Success Rate
Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)
Time frame: 25 days, 6 months post loading, and 12 months post loading
Implant Survival Rate
Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
Time frame: 7 days, 25 days, 6 months post loading, and 12 months post loading
Gingival Recession
Soft tissue measurements include: CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters.
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University of Washington
Seattle, Washington, United States
Time frame: 6 months to 12 months post loading
Number of Participants With Adverse Events and Adverse Device Effects
Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes "possibly related", "probably related" and "related").
Time frame: Duration of the study from surgical visit to the 12 months post-loading visit
Subject Satisfaction
Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain. General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain)
Time frame: 12 months post loading