The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).
Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement.
Private Practice
Yardley, Pennsylvania, United States
Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
Time frame: Six weeks following dental implant placement
Histological evaluation
Time frame: 6 months following tooth extraction
Alveolar ridge width and height changes
Time frame: 6 months following tooth extraction
Periodontal measurements
Time frame: 6 months following tooth extraction and 6 and 12 months following implant placement
Grafting procedure success rate
Time frame: 14 days, 1 month, 3 months, and 6 months following tooth extraction
Implant success and survival rate
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Mesial and distal implant bone level changes
Time frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Patient satisfaction
Time frame: 6 and 12 months following implant placement
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