Bone Grafting, Sinus Lifting
Conditions
Brief summary
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.
Interventions
DEVICEBone grafting on both sides
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 \[0.3-0.6 mm\]).
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Indication of bilateral sinus augmentation through lateral window technique to prepare maxillary right and left posterior edentulous sites for a single or multiple unit implant supported restorations. * Systemically healthy with controlled conditions * Periodontally healthy/controlled dentition * No known chronic and/or seasonal sinusitis * No previous ear, nose, throat, and sinus surgeries * Non-smokers * Willing to be treated with allograft, xenograft and/or synthetic bone graft materials
Exclusion criteria
* 1\. Indication of sinus augmentation through indirect techniques (≥5 mm initial alveolar ridge height from crest to maxillary sinus floor) * Implant placement surgery planned somewhere else * Implant placement planned at the time of sinus augmentation * Cases requiring major alveolar ridge augmentation concurrent with sinus augmentation * Cases requiring the use of a partial denture with buccal flange extension during the post-operative period * History of previously failed implant and/sinus augmentation procedures * History of tumors and/or radiation and/or chemotherapy * Uncontrolled systemic health problems and ENT/sinus concerns * Uncontrolled periodontal/dental problems * Intake of medications affecting wound or bone healing (e.g., corticosteroids, immunosuppressants, etc.) * Alcohol or drug abuse * Active smokers (patient should be a non-smoker for at least 1 year prior to sinus augmentation procedure) * Unable/unwilling to follow post-operative instructions, rejecting to be treated with allograft, xenograft and/or synthetic bone graft materials * Unable/unwilling to attend scheduled study visits * Participation in another clinical trial within 3 months prior to planned study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ridge dimensions | Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure | Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner |
| Change in Bone Density | Prior to the procedure; 4 months post-procedure | Bone density around the dental implant, measured via CBCT |
| Bone quality at 6 months | About 6 months post-grafting procedure | 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 |
| Patient-Centered Outcomes | Days 1-10 post-procedure | Participants will be asked to keep a diary to record pain level and pain medications taken. |
Countries
United States
Contacts
CONTACTBinnaz Leblebicioglu, DDS, MS, PhD
Outcome results
None listed