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NCT01842958 · ClinicalTrials.gov registry record · NA
Straumann Roxolid Multi-Center Study
A NA study of Jaw, Edentulous, Partially, sponsored by Institut Straumann.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT01842958: Completed NA study of Jaw, Edentulous, Partially, sponsored by Institut Straumann.
NCT01842958 is a NA study of Jaw, Edentulous, Partially that has completed, run by Institut Straumann. The registered enrollment target is 50 participants, below the 126-participant average among 5 other Jaw, Edentulous, Partially trials with a reported enrollment target (60% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842958, a NA study of Jaw, Edentulous, Partially, has completed, sponsored by Institut Straumann.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Straumann Bone Level Implants, 4.1 mm implant diameter
- DEVICE Straumann Bone Level Implants, 3.3 mm implant diameter
Study Locations (5)
California
- UCLA School of Dentistry - Los Angeles
Massachusetts
- Boston University, School of Dental Medicine - Boston
New York
- New York University College of Dentistry - New York
Texas
- Univeristy of Texas Health Science Center San Antonio - San Antonio
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT01842958 record still lists
NCT01842958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 126-participant average among 5 other Jaw, Edentulous, Partially trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Jaw, Edentulous, Partially appearing as the primary indexed condition, and to 2 interventions - of which Straumann Bone Level Implants, 4.1 mm implant diameter is the first listed.
NCT01842958 lists 5 locations in 5 states (California, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT01842958 about?
NCT01842958 is a clinical study titled "Straumann Roxolid Multi-Center Study". 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 ...
What is the current status of trial NCT01842958?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2013-03. Estimated completion is 2016-03.
What conditions does trial NCT01842958 study?
This clinical trial studies the following conditions: Jaw, Edentulous, Partially.
What interventions are being tested in trial NCT01842958?
The interventions under investigation include: Straumann Bone Level Implants, 4.1 mm implant diameter (DEVICE), Straumann Bone Level Implants, 3.3 mm implant diameter (DEVICE).
Who is sponsoring clinical trial NCT01842958?
This trial is sponsored by Institut Straumann, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01842958 being conducted?
This trial has 5 study locations across California, Massachusetts, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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