INFUSE Bone Graft Clinical Research
Clinical trials have shown INFUSEŽ Bone Graft to be a safe, effective bone graft alternative, with the added benefit of eliminating additional surgery to harvest autogenous bone.
INFUSEŽ Bone Graft has been studied in Level 1 multi-center randomized clinical trials that involved 248 patients.
The goal of the clinical trial program was to determine if INFUSEŽ Bone Graft could induce enough bone growth to support dental implants and, once the implants were restored, to determine whether the new bone produced by INFUSEŽ Bone Graft could successfully support the dental implants after two to three years of "functional loading," or chewing and biting.
Patients participating in these trials were candidates for either a sinus lift or an alveolar ridge augmentation following tooth extraction, and were provided either INFUSEŽ Bone Graft or the standard treatment for that procedure. Patients undergoing a sinus lift were randomly selected to receive either INFUSEŽ Bone Graft or have bone harvested from areas of their body, including their hip, tibia (leg) or chin (collectively referred to as autogenous bone harvest.) Patients undergoing an alveolar ridge augmentation were randomly selected to receive either INFUSEŽ Bone Graft, a placebo or no treatment. Regardless of the surgical procedure, in all studies the bone graft option was placed within the void or defect in the patient's jaw bone where bone growth was desired, and the bone growth results were compared.
The clinical studies achieved the primary goal: proving that INFUSEŽ Bone Graft is as effective as traditional surgical techniques. Of 99 patients evaluated in the pivotal sinus lift effectiveness study of INFUSEŽ Bone Graft, 83% produced enough bone to support dental implants without additional augmentation. Of those receiving dental implants, 93% of patients remained functionally loaded six months after crowns were placed on the implant posts and the patient started chewing.
Of the 58 patients in the study who underwent an alveolar ridge augmentation following tooth extraction, 74% of INFUSEŽ Bone Graft patients produced enough bone to support dental implants at six months of use, compared to only 50% of placebo patients and 38% of untreated patients who grew enough bone to support dental implants.
Clinical research also showed that INFUSEŽ Bone Graft is safe. Patients in the INFUSEŽ Bone Graft group also experienced significantly less pain and fewer complications than those receiving autogenous bone.
Key findings of the clinical trials with INFUSEŽ Bone Graft for oral and maxillofacial surgical applications include:
Find out if you are a candidate for INFUSEŽ Bone Graft.
For more information about INFUSEŽ Bone Graft, talk to your dental surgeon.
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