This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.
Study Type
OBSERVATIONAL
Enrollment
10
The surgical protocol is part of standard of care and will not be changed due to the study except the choice of the bone graft. Routinely (as the standard protocol), allograft (Straumann Allograft mineralized cortical granules \[0.25-1mm\]) is mixed with xenograft (bovine bone; Bio-Oss® small particles \[0.25-1mm\]) bone graft and placed into sinus. In this study, one randomly chosen sinus will receive this mixture (50:50 by volume) as the control. The other sinus on the same patient will receive a 50:50 (by volume) mixture of the same allograft with synthetic carbonate apatite (Cytrans® granules S size \[0.3-0.6 mm\]).
The Ohio State University College of Dentistry
Columbus, Ohio, United States
Change in ridge dimensions
Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner
Time frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure
Change in Bone Density
Bone density around the dental implant, measured via CBCT
Time frame: Prior to the procedure; 4 months post-procedure
Bone quality at 6 months
At implant surgery, 6 months post-grafting, a bone core sample will be taken. This tissue is normally removed during the implant procedure but it typically discarded. Histological analysis will be done on the sample
Time frame: About 6 months post-grafting procedure
Patient-Centered Outcomes
Participants will be asked to keep a diary to record pain level and pain medications taken.
Time frame: Days 1-10 post-procedure
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