The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.
This study is a post-market randomized study whereby each patient will receive 1 to 4 implants placed in the posterior maxilla or mandible. The primary objective of this randomized open study is to evaluate the performance in immediate and delayed loading (4 weeks) of Straumann standard solid screw 4.1mm and the 4.8 mm diameter wide neck implants with a new surface. These implants will support single crowns or 2 to 4 unit bridge restorations in the posterior maxilla or mandible and the treatment will be evaluated for the immediate and delayed loading procedures at one year post surgery. Patients will be allocated into two groups and then randomized into immediate or delayed loading arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery. Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery. In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.
Private Practice
Boca Raton, Florida, United States
Private Practice
Indianapolis, Indiana, United States
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 1 year post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 2 years post-surgery
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
Time frame: Change in crestal bone level from surgery (baseline) to 3 years post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation
Time frame: 20-23 Weeks post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 1 year post-surgery
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 2 years post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Tiroler Landeskrankenanstaltengesellschaft mbH
Innsbruck, Austria
Praxisklinik fur Mund- Keifer- und Gesichtschirurgie
Bochum, Germany
Private Practice
Fürth, Germany
Klinikum Nord-Heidberg
Hamburg, Germany
Private Practice
Weiden, Germany
Private Universitat Witten
Witten, Germany
Queens University
Belfast, Ireland
...and 9 more locations
Implant Survival
Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation
Time frame: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected
Patients affected by AE Patients affected by related/ unknown AE
Time frame: until the 3 year post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 20-23 weeks post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 1 years post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 2 years post-surgery
Implant Success
Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant
Time frame: 3 years post-surgery
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events
Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)
Time frame: until the 3 year post-surgery