Clinical Trial: Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Graftless Maxillary Sinus Augmentation With CGF Utilizing DIVA System
Brief Summary: This study is intended to evaluate the efficiency of graftless maxillary sinus augmentation with concentrated growth factor (CGF) utilizing "dynamic implant valve approach" (DIVA) system.
Detailed Summary:
Crestal bone deficiency in the posterior maxilla may present a therapeutic challenge when dental implants are required. Sufficient bone volume is necessary for the long term survival of the implant .
The two most used surgical techniques are the crestal and the lateral window. The latter was first described by Tatum and subsequently, Boyene and James in 1980 . In the original technique, after fracturing the sinus floor, an implant was placed and submerged during the healing phase. The crestal osteotome technique is less invasive and was first described by Summers in 1994 . In this technique, a set of osteotomes is used to prepare the implant site, thereby allowing bone preservation.
Since the sinus augmentation was describes, bone grafts have been the mainstay of treatment. Variable bone grafts, such as autografts, allografts, xenografts, alloplasts, or combinations of different graft materials, have been used widely with similar results . Nonetheless, successful bone augmentation in the maxillary sinus, without bone grafting, have been reported in human and animal studies.
In 2011, Dong-Seok et al described sinus augmentation through a lateral window approach, using a fibrin rich block with concentrated growth factor (CGF). The researchers showed successful new bone formation in the sinus, with a success rate of 98% and no major complications .
Graftless Sinus augmentation relies on bioactive mediators that stimulate cell proliferation, matrix remodeling, and angiogenesis. CGF is one of the latest developments in this field, and is produced by processing blood samples with a special centrifuge device. It contains several mediators - platelet-derived growth factor (PDGF), transforming growth factor-b1 (TGF-b1) and b2 (TGF-b2
Sponsor: Western Galilee Hospital-Nahariya
Current Primary Outcome: bone formation after sinus augmentation [ Time Frame: one year ]
during postoperative follow-up, bone formation in the maxillary sinus will be assessed by periodic imaging.
after one year the investigators expect to see complete implant integration into the bone formed in the maxillary sinus(e.g; the dental implant is completely covered by bone).
Original Primary Outcome: bone formation after sinus augmentation [ Time Frame: one year ]
during postoperative follow-up, bone formation in the maxillary sinus will be assessed by periodic imaging.
after one year we expect to see complete implant integration into the bone formed in the maxillary sinus(e.g; the dental implant is completely covered by bone).
Current Secondary Outcome: Quantification of growth factors released from the CGF matrix in vitro [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Western Galilee Hospital-Nahariya
Dates:
Date Received: November 26, 2016
Date Started: December 2016
Date Completion: January 2018
Last Updated: December 6, 2016
Last Verified: December 2016
