The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Dr. Jeffery Ganeles
Boca Raton, Florida, United States
Dr. William C. Martin
Gainesville, Florida, United States
Dr. Stephen T. Chen
Melbourne, Australia
Prof. Wiltfang
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Time frame: Baseline and 6 months
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Time frame: 6 months
Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kiel, Schleswig-Holstein, Germany
Michael Gahlert
München, Germany
Katharinenhospital
Stuttgart, Germany
Private Universität Witten/ Herdecke
Witten/ Herdecke, Germany
Dr. Luca Cordaro
Rome, Italy
Prof. Mariano Sanz
Madrid, Spain
Dr. Carl-Johan Ivanoff
Mölndal, Sweden
...and 1 more locations