Straumann Roxolid Multi-Center Study
|ClinicalTrials.gov Identifier: NCT01842958|
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous, Partially||Device: Straumann Bone Level Implants, 4.1 mm implant diameter Device: Straumann Bone Level Implants, 3.3 mm implant diameter||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized, Controlled, Multi-center Clinical Study Evaluating the Crestal Bone Level Changes of Straumann BL Ø 3.3 mm NC SLActive RXD Implants Compared to Straumann BL Ø 4.1 mm RC SLActive RXD Implants for Single Tooth Replacement.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: 4.1 mm implant diameter
Placement of a Straumann Bone Level Implants, 4.1 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Device: Straumann Bone Level Implants, 4.1 mm implant diameter
Straumann Bone Level Implants, 4.1 mm implant diameter
Experimental: 3.3 mm implant diameter
Placement of a Straumann Bone Level Implants, 3.3 mm implant diameter, for single tooth replacement in the anterior and pre-molar region
Device: Straumann Bone Level Implants, 3.3 mm implant diameter
Straumann Bone Level Implants, 3.3 mm implant diameter
- Mean Crestal Bone Level Change [ Time Frame: Baseline (implant placement) and 12 months post loading ]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.
- Additional Mean Crestal Bone Level Changes [ Time Frame: Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading ]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
- Implant Success Rate [ Time Frame: 25 days, 6 months post loading, and 12 months post loading ]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)
- Implant Survival Rate [ Time Frame: 7 days, 25 days, 6 months post loading, and 12 months post loading ]Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)
- Gingival Recession [ Time Frame: 6 months to 12 months post loading ]
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.
- Number of Participants With Adverse Events and Adverse Device Effects [ Time Frame: Duration of the study from surgical visit to the 12 months post-loading visit ]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").
- Subject Satisfaction [ Time Frame: 12 months post loading ]
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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842958
|United States, California|
|UCLA School of Dentistry|
|Los Angeles, California, United States, 90095-1668|
|United States, Massachusetts|
|Boston University, School of Dental Medicine|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|New York University College of Dentistry|
|New York, New York, United States, 10019-5404|
|United States, Texas|
|Univeristy of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-7444|
|Principal Investigator:||David L. Cochran, DDS, MS, PhD||University of Texas Health Science Center San Antonio|