The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months. In total 8 visits per patient are scheduled in this study. The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication. One center in Beligum will participate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Bone augmentation procedure performed with Bone Ceramic
Bone Augmentation procedure performed with Bio Oss
Katholieke Universiteit Leuven
Leuven, Belgium
Change of Vertical Height of Buccal Defects
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Time frame: Baseline to 26 weeks
Implant Success Rate
The success of oral implant will be determined according to the following parameters: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility (based on hand testing) * Absence of a peri-implant infection with suppuration. * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). * Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Time frame: 6 months
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility. * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). * Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Time frame: 6 Months
Implant Success Rate
The success of oral implant will be determined according to the following parameters: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility (based on hand testing) * Absence of a peri-implant infection with suppuration. * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). * Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
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Time frame: 12 months
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility. * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). * Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Time frame: 12 months