98% Success Rate in Sinus Augmentations with Bio-Oss and Bio-Gide
A Clinical Study of 406 Sinus Augmentations With 100% Anorganic
Bovine Bone
Carlos E.A. Ferreira, Arthur B. Novaes Jr, Violet I. Haraszthy, et al.
J Periodontology 2009;80:1920-1927
Purpose
Maxillary sinus augmentation procedures are frequently required prior to implant placement in the posterior maxilla. In a prospective radiographic, histologic and histomorphometric clinical trial, implant survival, percent bone regeneration, percent marrow space and percent residual particulate graft remaining in sinuses grafted with 100% Bio-Oss® were studied at various time points following initial grafting.
Materials & Methods
Ninety-two patients requiring bilateral sinus augmentations and 222 needing unilateral sinus grafts were enrolled in this study. A total of 1,025 implants were placed in the grafted sites, 118 placed simultaneously with the Bio-Oss® grafts and 907 inserted 6 –12 months following augmentation surgery. Lateral window osteotomy sites were covered with a Bio-Gide® resorbable collagen membrane. Patients were followed clinically every six months, with radiographic examination once yearly for 3 years. Implant survival was defined as the absence of pain and mobility after each follow-up examination up to 3 years.
In 7 cases chosen randomly, biopsy specimens were harvested from the lateral window osteotomy site 10 – 12 months following graft surgery (mean: 11.4 months) for histologic and histomorphometric examination.
Results
Clinical Survival Rates
Of the 1,025 implants placed into 406 grafted sinuses, 19 implants required removal, for an overall survival rate of 98.1%. Of the implants lost, 4 were placed simultaneously at the time of grafting (survival rate: 97.0%) and 15 placed in 2 stages (survival rate: 98.3%).
Radiographic Results
The amount of native subsinus bone was calculated radiographically in the immediate postoperative panoramic radiograph for each implant placed. As noted in the following table, implant survival rates were statistically the same regardless of the amount of native bone present at the time of implant placement.
It is interesting to note that the amount of native bone present at the time of implant placement did not seem to significantly influence survival rates.
Histologic & Histomorphometric Results
Histologic and histomorphometric examination at 10 – 12 months post-grafting with Bio-Oss® revealed the following findings:
- Newly regenerated bone occurred adjacent to residual Bio-Oss® particles in all specimens.
- Bio-Oss® particles were also seen adjacent to normal bone marrow spaces.
- Active resorption of Bio-Oss® particles was frequently observed.
As noted in the chart below, a mean of 38.95% new bone formation occurred after 10 – 12 months of grafting with Bio-Oss®. The percentage of Bio-Oss® (ABB) particles remaining was approximately 8%.
Conclusions
This large, long-term prospective study validates the use of 100% Bio-Oss® and Bio-Gide® for sinus augmentation procedures. The high 98.1% implant survival rate also supports the use of Bio-Oss® and Bio-Gide® in both single and dual staged maxillary sinus procedures and is consistent with prior published literature, including several systematic reviews.
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