Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone graft patients | Patients who are missing their upper back teeth and interested in having implant supported dental restorations, and who require direct sinus augmentation procedure on both right and left maxillary sinus prior to implant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone grafting on both sides | Device | 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]). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ridge dimensions | Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner | 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 | 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 | 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. | Days 1-10 post-procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who missing their upper back teeth (both sides) and interested in having implant supported dental restorations
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binnaz Leblebicioglu, DDS, MS, PhD | Contact | 614-292-0371 | leblebicioglu.1@osu.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Dentistry | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|