Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
The University of Iowa College of Dentistry
Iowa City, Iowa, United States
University of Maryland School of Dentistry
Baltimore, Maryland, United States
Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Time frame: Baseline and 4 months post-surgery
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.
Time frame: Baseline and 4 months post-surgery
Histomorphometric Assessment of Newly Formed Mineralized Tissue
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of mineralized tissue respective to the percent of the total core area.
Time frame: 5 months post-surgery
Histomorphometric Assessment of Residual Bone Graft Particles
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of residual bone graft respective to the percent of the total core area.
Time frame: 5 months post-surgery
Histomorphometric Assessment of Non-mineralized Tissue
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of non-mineralized tissue respective to the percent of the total core area.
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Time frame: 5 months post-surgery
Change of Marginal Bone Level Around Dental Implant
Linear measurement of marginal bone level (MBL) in millimeters along mesial and distal dental implant surface are captured in periapical standardized radiographs at crown delivery (baseline), 6, and 12 months after crown delivery. Change of MBL = (Baseline measurement - 6 or 12 months measurement)
Time frame: Baseline, 6, and 12 months after crown delivery