Case Report. RapidSorb Rapid Resorbable Fixation System. Ridge augmentation in a one-step surgical protocol.

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1 Case Report RapidSorb Rapid Resorbable Fixation System. Ridge augmentation in a one-step surgical protocol.

2 RapidSorb Rapid Resorbable Fixation System. Ridge augmentation in a one-step surgical protocol. Patient Profile A healthy 39-year-old was referred by her restorative dentist for definitive treatment of the mandibular central incisors in conjunction with comprehensive orthodontics. The patient presented with generalized moderate gingivitis and lower anterior crowding. Examination revealed localized hypermobility and >50% horizontal bone loss around endodontically-treated and crowned teeth #24 and #25. The long-term prognosis for these teeth, particularly after orthodontic movement, was poor. Both #24 and #25 were treatment planned for extraction with localized ridge augmentation to facilitate future placement of dental implants. Presurgical Planning After three months of orthodontics to create the desired arch form (Figure 1), a preoperative cone-beam CT scan was taken to identify the location of the lingual vessels and evaluate the thickness of the alveolar bone around the mandibular central incisors. The scan revealed complete loss of buccal alveolar bone in the anterior mandible (Figure 2). It was anticipated that bone grafting alone would result in a knife-edged alveolar ridge and would not provide the desired width and crestal height of bone for implant placement. To decrease the likelihood of this unfavorable result, the clinician used Synthes RapidSorb system for three-dimensional bone maintenance. By acting as a substrate for bone graft containment, RapidSorb mesh serves to optimize the bone volume gained from ridge augmentation procedures. Figure 1 Figure 2 Synthes RapidSorb Rapid Resorbable Fixation System Case Report

3 RapidSorb Surgical Treatment The surgical site was accessed via sulcular incision from the distal of the adjacent teeth, with vertical releases on the distolingual. The central incisors were extracted atraumatically, revealing the severe buccal and lingual alveolar defects (Figure 3). The extraction sites were then grafted with 0.5 cc of Synthes/MTF mineralized cortical allograft. The sites were intentionally overfilled, with bone graft material extending coronally to the desired height and width of crestal bone (Figure 4). After grafting, a 50 mm x 50 mm x 0.5 mm thick RapidSorb mesh was cut and contoured in a 70 C, sterile water bath for approximately 30 seconds. The mesh was then adapted around the grafted site (Figure 5). Once placed, the mesh regains rigidity in less than 10 seconds. To ensure adequate stiffness and prevent displacement, the mesh was fixated on the facial with two 6 mm long RapidSorb screws. The resorbable screws were pretapped and placed 6 mm below to the apices of the adjacent teeth. The mesh lay passively over the lingual cortex, and did not require further lingual stabilization. After placement, the mesh will fully resorb over a 12-month period. Figure 3 Extensive buccal dehiscence of extraction sites. Figure 4 Synthes/MTF bone graft placed in and coronal to extraction sites. Figure 5 RapidSorb mesh adapted to ridge and affixed with resorbable screws. RapidSorb Rapid Resorbable Fixation System Case Report Synthes 1

4 RapidSorb Rapid Resorbable Fixation System. With the RapidSorb mesh in place to contain the graft, Synthes/MTF DermaMatrix Acellular Dermis was placed on top of the mesh to ensure an adequately thick band of keratinized tissue at the future implant sites. A mm thick piece of DermaMatrix was positioned with its connective tissue surface facing the periosteum of the surgical site (Figure 6). The extraction site was then closed tension-free with a 5-0 resorbable suture. Horizontal mattress sutures were used to close the vertical releases, with continuous interlocking sutures used in the area of the osseous crest (Figure 7). Postoperative Care At the three-month postoperative visit, a small (2 mm x 2 mm) exposure of the mesh in the distolingual area of tooth #24 was noted. No treatment was indicated or rendered, and the site displayed complete soft tissue coverage at a follow-up visit four weeks later. Figure 6 DermaMatrix in place over RapidSorb to augment attached soft tissue Figure 7 2 Synthes RapidSorb Rapid Resorbable Fixation System Case Report

5 Implant Planning and Surgical Treatment After approximately 6 months of healing, a CT scan was taken to evaluate the width and height of the augmented ridge available to perform a flapless implant placement surgery. Implant-planning software (SimPlant, Materialise Dental) was used to virtually place implants in an ideal position on the regenerated ridge (Figure 8). The results verified that the single RapidSorb mesh and bone grafting surgery provided adequate bone augmentation for the patient to undergo flapless implant surgery and avoid additional grafting. Guided surgery templates (Figure 9) were fabricated from the CT data to enable precise placement and angulation of implants replacing teeth #24 and #25. The planned implant diameter was 3.0 mm, to provide acceptable interimplant and tooth-implant distances. The narrow diameter of the selected implant made it possible to use a classic guide (Materialise), which provides lateral but not depth control. Multiple guides, each with sleeves to accommodate the manufacturer- recommended drill size, were fabricated and used sequentially during implant placement (Figure 9), planning and fabrication of surgical guide. Two 2.5 mm tissue punches provided access to the predetermined crestal ridge osteotomy sites (Figure 10). The templates developed from the planning software were firmly seated on the mandibular teeth to guide implant drills in both sites. Osteotomies were slightly underprepared to receive two 3.0 mm x 13.0 mm implant fixtures with primary stability. 4.0 mm x 2.0 mm transmucosal healing abutments were then tightened in place, eliminating the need for a second stage surgery (Figure 11). The patient returned to the orthodontist office immediately after the surgery, where two denture teeth bonded to an arch bar were inserted into the existing ortho brackets. Definitive restorations were planned for insertion 8 to 10 weeks after implant placement. Figure 8 Software for implant placement Figure 9 - Guided surgery templates Figure 10 Flapless entry to osteotomy sites Figure 11 Healing abutments placed the same day RapidSorb Rapid Resorbable Fixation System Case Report Synthes 3

6 RapidSorb Rapid Resorbable Fixation System. Discussion Alveolar ridge augmentation is often required to enable the desired placement of dental implants. However, the morbidity associated with autogenous bone grafting procedures has left clinicians to seek alternative products and techniques to regenerate lost or damaged alveolar bone. Rigid meshes are a natural choice for these procedures, due to their spacemaintaining properties. Conventional titanium meshes have proven effective in recent years. Unfortunately, subsequent surgical removal of the titanium mesh is mandatory, either prior to or concurrent with implant placement. Shortcomings also include premature mesh exposure, which can require early removal and result in suboptimal regenerative results. A resorbable mesh, capable of the same space-maintaining properties of conventional meshes, provides several advantages over conventional titanium. First, early exposure can often be managed without premature mesh removal and additional surgery. In addition, when adequate ridge dimensions are achieved, it is possible to perform minimally-invasive surgery without reflecting a full-thickness flap. A secondary objective of ridge augmentation is to achieve adequate keratinized soft tissue around future implant sites. For those cases with adequate hard and soft tissue volume which do not require surgical removal of titanium meshes or bone block fixation screws, a guided, flapless surgery can be considered. Figure 12 - Implants in place "The virtue of RapidSorb, not to mention the spacemaintenance and ease of use, is the elimination of the removal procedure. When augmented ridges provide ideal contours and tissue volume, minimally-invasive implant placement is a reality and a great service to our patients. This is not possible with titanium mesh, non-resorbable, reinforced membranes and block-fixation screws. Barry P. Levin, DMD Note: Results from case studies are not necessarily predictive of results in other case studies. Results in other cases may vary. 4 Synthes RapidSorb Rapid Resorbable Fixation System Case Report

7 Common sizes for intraoral applications 1.5 mm RapidSorb Resorbable Mesh, sterile Thickness Sizes S 0.25 mm 50 mm x 50 mm S 0.25 mm 50 mm x 50 mm S 0.25 mm 30 mm x 40 mm S 0.25 mm 20 mm x 30 mm S 0.25 mm 15 mm x 25 mm S 0.5 mm 30 mm x 40 mm S 0.5 mm 20 mm x 30 mm S 0.5 mm 15 mm x 25 mm 1.5 mm Rapid Resorbable Cortex Screws, sterile (2/pkg.) Length S 3 mm S 4 mm S 5 mm S 6 mm S 8 mm 2.0 mm Rapid Resorbable Cortex Screws (Emergency Screws), sterile (2/pkg.) Length S 4 mm S 6 mm S 8 mm Graft materials used in this case study DermaMatrix Acellular Dermis (Synthes/MTF) Thin Tissue Size Thickness Thickness (cm) (mm) (inches) x x x x x Thick Tissue x x x x Mineralized Cortical Powder (Synthes/ MTF) Part Number Volume cc cc cc cc RapidSorb Rapid Resorbable Fixation System Case Report Synthes 5

8 Surgeon profile Barry P. Levin, DMD Clinical Associate Professor, Dept. of Periodontology, University of Pennsylvania Private Practice Limited to Periodontics, Elkins Park, PA Diplomate, American Board of Periodontology ITI Fellow For more products, contact your local Sales Consultant, or our Dentoalveolar Surgery Products reference line at (800) , or Synthes 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes, Inc. or its affiliates. All rights reserved. DermaMatrix, RapidSorb and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 5/12 J10479-Bwww.synthesdento.com Musculoskeletal Transplant Foundation 125 May Street Edison, NJ Telephone: (732) Fax: (732)