XiVE® CAD/CAM Bridges (Abutment-supported/ Implant-supported) (XiCC)
|Partly Edentulous Maxilla||Device: Abutment-supported XiVE CAD/CAM bridge Device: Implant-supported XiVE CAD/CAM bridge|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Prospective, International, Multi-center Clinical Study to Evaluate the Peri-implant Tissue Outcome of Abutment-supported XiVE® CAD/CAM Supra-structures and Directly Implant-supported XiVE® CAD/CAM Supra-structures (Split-mouth) in Partly Edentulous Human Subjects.|
- Mean change of bone level [ Time Frame: 0, 12, 24 months ]
Intra-oral radiographs from implant insertion and at time for prosthesis insertion as well as from 1 and 2-year follow-up visits (calculated from the time of loading) should be taken for evaluation of bone level. All radiographs will be examined by an independent dentist.
For the purpose of this examination XCP film holder (DENTSPLY Rinn, 1212 Abbott Drive, Elgin, Illinois 60123-1819, USA) are individualized for each subject and for each x-ray.
- Sulcus-fluid-flow-rate [ Time Frame: 6 weeks, 6, 12, 24 months ]The evaluation of the sulcus fluid flow rate (SFFR) is a common method for the objective definition of the gingiva inflammation level in clinical research. The SFFR is measured with the electronic sulcus fluid hygrometer, Periotron model 600 A No. 700702 (Harco Electronics Ltd., Canada) and always as the first procedure in order not to be influenced by other investigation parameters.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Abutment-supported XiVE CAD/CAM bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed on an abutment.
Device: Abutment-supported XiVE CAD/CAM bridge
One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
Active Comparator: Implant-supported XiVE CAD/CAM bridge
After randomization one side of the jaw will be provided with a XiVE CAD/CAM bridge placed directly on an implant.
Device: Implant-supported XiVE CAD/CAM bridge
One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
The planned study profile is to assess the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration. Two treatments, Treatment A which is the abutment-fixed supra-structure and Treatment B, the direct implant-fixed restoration, are assessed within the scope of this clinical investigation.
Treatment A: The XiVE® CAD/CAM supra-structure is fixed on abutments. The effect of platform-switching which is discussed intensely in the scientific literature is used in order to shift away the connection between implant and supra-construction (interface) from the implant edge and peri-implant tissue and towards the implant centre. However, the implant-abutment-connection area is a potential entry port for micro-organisms which have direct influence on the state of the peri-implant hard and soft tissue and consequently on the long-term prosthetic and implant success . By using an abutment as a connector between implant and supra-structure implies the generation of one more micro-gap (between supra-structure and abutment) and possible retention of microbial plaque though located above the hard tissue level.
Treatment B: The XiVE® CAD/CAM supra-structure is fixed directly on the implants. In contrary to treatment A, only one entry port (micro-gap) for micro-organisms exists: The interface between supra-construction and implant. So, there is one main point where the initial force has main influence on the implant and the peri-implant tissue [8-10]. Besides, this interface lies directly on the implant shoulder level and by that on the osseous level. There is no displacement of the transitional area to the implant centre.
This study has been designed in order to collect data with regards to the CAD/CAM system used on the DENTSPLY Friadent implant system XiVE®. In particular, the peri-implant tissue outcome of abutment-supported restoration and direct implant-fixed restoration will be evaluated. Therefore a small group of subjects with partly edentulous jaw is selected to show that both techniques are efficient and safe and to demonstrate the non-inferiority with regards to the peri-implant tissue outcome for any of both techniques.
Each subject will receive both treatments, treatment A on the one site of the maxilla and treatment B on the other. The randomization method which finally defines which subject receives one treatment on the left maxilla region and the other on the right maxilla area or vice versa is described in section 5.1.
In conclusion, both treatments might have pros and cons which may affect the peri-implant tissue outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522365
|Erlangen University Hospital|
|Erlangen, Germany, 91054|
|University of Birmingham, School of dentistry|
|Birmingham, United Kingdom, B4 6NN|
|Principal Investigator:||Manfred Wichmann, Prof. Dr.||Erlangen University Hospital|
|Principal Investigator:||Thomas Dietrich, Prof. Dr. Dr.||Birmingham University, School of Dentistry|