Regeneration Bone Grafting & Soft Tissue Management

Transcription

1 Regeneration Bone Grafting & Soft Tissue Management

2 OSTEON TM

3 Table of Contents Bone Graft Material OSTEON TM II Collagen 04 OSTEON TM Collagen 06 OSTEON TM II (Sinus & Lifting) 08 OSTEON TM (Sinus & Lifting) 12 ORTHOPEDIC OSTEON TM 14 Membrane OSTEOGuide TM 15 Collagen Membrane 16 HA Collagen Membrane 18 Documentation Summaries Bone Graft Material Clinical Evaluation of OSTEON as New Alloplastic Material in Sinus Bone Grafting and Effect on Bone Healing 21 Analysis of the healing process in sinus bone grafting using various grafting materials 24 Sinus bone graft using new alloplastic bone graft material(osteon)-ii : clinical evaluation 25 Effects of 4 Different Alloplastic Materials on Bone Regeneration in Rabbit Calvarial Defects 26 Case series of maxillary sinus augmentation with biphasic calcium phosphate: a clinical and radiographic study 28

4 04 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Il Collagen Application of OSTEON TM II Collagen Simple grafting (volume up) Ridge augmentation Extraction site & osteotomy Cystic cavities Periodontal defect Characteristics of OSTEON TM II Collagen Bone void filler composed of synthetic bonegraft(osteon TM II) and natural type I collagen Moldable to various defect shape after being wet Easy handling, thus shortened operation time OSTEON TM II is highly resorbable due to higher -TCP content (HA: -TCP=30:70) Collagen is absorbed over several weeks after helping the initial shaping SEM image In Vitro Dissolution Test of OSTEON TM II Animal Test Animals : New Zealand white rabbit Implantation Area : Femur Period : 6 weeks CT image

5 Regeneration Bone Grafting & Soft Tissue Management 05 Products Type REF Size Particle Size (mm) Cylinder OTCC0605S OTCC0610S Ø6.0 x 5.0 mm Ø6.0 x 10.0 mm 0.2~0.5 mm Clinical Case Ridge augmentation GBR

6 06 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Collagen Application of OSTEON TM Collagen Ridge augmentation Extraction site & osteotomy Cystic cavities Sinus lift Periodontal defect Description OSTEON TM Collagen is a bone void filler composed of synthetic bone(osteon TM ), and natural type I collagen. Characteristics of OSTEON TM Collagen Collagen coating enables easy handling, and thus shortened operation time Moldable to various defect shape after being wet Collagen dissolves after helping the initial handling Excellent new bone formation and space maintenance Hemostatic function Highly pure type I collagen derived from bovine tendon Cell Adhesion Test Osteoblasts spread well on the OSTEON TM Collagen X 1000 X 5000

7 Regeneration Bone Grafting & Soft Tissue Management 07 Animal Test 8 weeks 1. Animals: new zealand white rabbit 2. Implantation area: calvaria 3. Period: 8 weeks 4. Staining method: goldner trichrome Products Type REF Size (mm) Particle Size (mm) Cylinder GOCC0605 Ø6.0 x 5.0 GOCC0610 Ø6.0 x ~ 1.0 Clinical Case Ridge augmentation Ridge preservation Full mouth rehabilitation

8 08 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM II (Sinus & Lifting) Application of OSTEON TM II Ridge augmentation Extraction site & osteotomy Cystic cavities Sinus lift Periodontal defect Composition of OSTEON TM II Osteoconductive biphasic calcium phosphate with higher -TCP OSTEON TM II = HA 30% + -TCP 70% Characteristics of OSTEON TM II Highly resorbable due to higher -TCP content Easy manipulation Excellent wettability Osteoconductive synthetic bonegraft Pore size : 250 Porosity : 70% Cell Adhesion Test Osteoblasts attached & spreaded well In Vitro Dissolution Test

9 Regeneration Bone Grafting & Soft Tissue Management 09 Animal Test 12-weeks follow up in rabbit calvaria model OSTEON TM OSTEON TM II Products Type REF Volume (cc) Particle Size (mm) DT7G DT7G ~0.5 Vial Sinus Lifting DT7G DT7G DT7G DT7G DT7G DT7G DT7G DT7G SS 0.5 DT7G SS 0.5 DT7G LS 0.25 DT7G LS ~ ~ ~ ~ ~ ~1.0 Clinical Case GBR

10 10 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM (Sinus & Lifting) Application of OSTEON TM Ridge augmentation Extraction site Cystic cavities Sinus lift Periodontal defect Composition of OSTEON TM 100% Synthetic bone graft : HA scaffold coated with -TCP OSTEON TM = HA 70% + -TCP 30% Specification of OSTEON TM 100% synthetic bone graft Interconnected porous structure similar to that of human cancellous bone Osteoconductive material as a bone growth scaffold OSTEON TM Human bone Cell Adhesion Test Human osteoblast cell OSTEON TM Osteoblast cell was well attached and spreaded on OSTEON TM surface. X 1000 X 1000 X 5000

11 Regeneration Bone Grafting & Soft Tissue Management 11 Human Histology 6.5 months after sinus graft surgery New bone OSTEON TM 0.5mm 0.25mm OSTEON TM area = 1.24mm 2 (17.1%) New bone area = 1.63mm 2 (22.7%) 10 months after sinus graft surgery OSTEON TM New bone 1.0mm 1.5mm OSTEON TM area = 3.04mm 2 (35.5%) New bone area = 2.38mm 2 (27.7%) 21 months after sinus graft surgery OSTEON TM New bone 0.5mm 0.25mm OSTEON TM area = 6.30mm 2 (40.4%) New bone area = 5.12mm 2 (33.0%)

12 12 Regeneration Bone Grafting & Soft Tissue Management Products Product REF Particle Size (mm) Volume (cc) GBG ~0.5 Vial GBG ~ / 0.5 / 1.0 GBG ~2.0 Sinus GBG0510SS 0.5~1.0 GBG1020SS 1.0~ Lifting GBG0305LS 0.3~0.5 GBG0510LS 0.5~ Syringe Product O.D. I.D. OSTEON TM Sinus Ø7.0mm Ø5.0mm OSTEON TM Lifting Ø5.0mm Ø3.4mm O.D. : syringe outer diameter I.D. : syringe inner diameter

13 Regeneration Bone Grafting & Soft Tissue Management 13 Instruction for OSTEON TM Sinus & Lifting Slightly retract the plunger and gently tap to loosen particles. Gently push plunger back into place. Place syringe into a sterile dappen dish and retract plunger to draw liquid into the syringe. To optimize delivery, OSTEON TM should be wetted and loosened sufficiently. Expel excess liquid by applying very gentle pressure on the plunger. When sufficiently hydrated, OSTEON TM will expel with ease from the syringe. Before injecting OSTEON TM, remove the cap from the syringe. Deliver OSTEON TM directly into the surgical site with the syringe. Clinical Case OSTEON TM Sinus case (Sinus grafting - lateral approach) After 9 months OSTEON TM Lifting case (Sinus grafting - crestal approach)

14 14 Regeneration Bone Grafting & Soft Tissue Management ORTHOPEDIC OSTEON TM Application of ORTHOPEDIC OSTEON TM Bone filling Fractures with bone defects Pseudoarthrosis with or without bone defects Tibial osteotomy In certain cases of arthroplasty revision Products Product REF Particle Size (mm) Volume (cc) ORTHOPEDIC OSTEON GOBG ~4.0 GOBG ~ / 4.0 / 5.0 / 10.0 / 15.0 / 20.0 GOBG0510, GOBG1020, GOBG2030, GOBG3040, GOBG4050 are available. Animal Test - Rabbit Femur Model X 12.5 X weeks after bone grafting in rabbit femur. After bone grafting in rabbit femur for 12 weeks, new bone was well formed in the pores and around ORTHOPEDIC OSTEON TM. Clinical Case Bone void filler

15 Regeneration Bone Grafting & Soft Tissue Management 15 OSTEOGuide TM Description Non-resorbable GBR membrane Biocompatible polymer PCL Thin for easy manipulation Porous membrane Products Product REF Size (mm) Thickness (mm) GPM X 20 OSTEOGuide TM GPM X GPM X 40 Composition of OSTEOGuide TM Bio-compatible polymer = 100% PCL (Polycaprolactone) The porous outer surface of the OSTEOGuide TM allows easy entry of the adjacent cells assuring rapid and good tissue attachment. Good nutrient flow and blood vessel formation supported by the porous structure. Animal test - rabbit calvaria model New bone was well formed on the bottom of the OSTEOGuide TM and cells did not penetrate into the defect. Soft tissue OSTEOGuide TM

16 16 Regeneration Bone Grafting & Soft Tissue Management Collagen Membrane Application of Collagen Membrane Biodegradable barrier membrane for guided bone / tissue regeneration Periodontal / infrabony defects Ridge augmentation Extraction sites (implant preparation / placement) Sinus lift Characteristics of Collagen Membrane Easy manipulation Dual-sided usage Barrier function lasting for 6 months Highly pure type I collagen derived from bovine tendon Thinner membrane(300 ) with multiple layers for easy manipulation and sufficient mechanical strength in surgery. Resorption period of 6 months to provide enough time for stabilizing graft materials and supporting bone growth. Multiple-layered structure enables more effective bone regeneration by sparing enough space for hard tissue formation and facilitates proliferation of osteoblast. SEM Image X 1000 X 5000

17 Regeneration Bone Grafting & Soft Tissue Management 17 Preclinical Data Rabbit calvaria bodel, 6-12 weeks Degradation character in collagenase solution 6 weeks 12 weeks Products Product REF Size (mm) Thickness (mm) GCM X 20 Collagen Membrane GCM X GCM X 30 Clinical Case GBR GBR

18 18 Regeneration Bone Grafting & Soft Tissue Management HA Collagen Membrane Application of HA Collagen Membrane Resorbable collagen membrane containing hydroxyapatite (HA) particles Periodontal / Infrabony defects Ridge augmentation Extraction sites Guided Bone Regeneration(GBR) procedure Sinus lift Characteristics of HA Collagen Membrane Resorbable barrier membrane Osteoconductive due to HA particles New bone formation through the membrane Highly pure type I collagen derived from bovine tendon Cell Adhesion Test MC3T3 / E1 (Osteoblast cell) X 500 Microstructure X 100 X 70000

19 Regeneration Bone Grafting & Soft Tissue Management 19 Animal Test Rabbit calvaria model, 12 weeks Products Product REF Size (mm) Thickness (mm) GCHM X 20 HA Collagen Membrane GCHM X 20 GCHM X Clinical Case GBR Socket preservation

20 20 Regeneration Bone Grafting & Soft Tissue Management Documentation Summaries Bone Graft Material Interconnected Pore

21 Regeneration Bone Grafting & Soft Tissue Management 21 Kim et al., J. Biomed. Mat. Res. B (2008) Clinical Evaluation of OSTEON as New Alloplastic Material in Sinus Bone Grafting and Effect on Bone Healing Young-Kyun Kim, 1 Pil-Young Yun, 1 Sung-Chul Lim, 2 Su-Gwan Kim, 3 Hyo-Jung Lee, 4 Joo L. Ong 5 Jounal of Biomedical Materials Research Part B. Applied Biomaterials vol 86 page 270~277 This is the summary of Clinical Evaluations OSTEON as a New Alloplastic Material in Sinus Bone Grafting and its effects on Bone Healing which is published at Journal of Biomedical Material Research Part B, written by Prof. Young-Kyun Kim. Introduction. Placement of implant prosthesis in the maxillary posterior region is known to be difficult on many aspects and has lowest success rate. In many clinical situations, the maxillary region is made of type III or IV bone with porous and insufficient bones for implant placement. The advancement in implant surgical techniques, improved bone graft, and recent development in implant surface treatments have resulted in predictable sinus bone graft success, thereby allowing implant placement in the maxillary molar region. However, controversy still exists on what constitute an ideal sinus graft materials. Ideally, the bone graft material used for implant reconstruction should (a) maintain space an optimal period of time to achieve bone in growth and implant healing, (b) remain stable for the period of graft consideration, during implant integration, and after the implants are restored, (c) promote osteoconduction of the neighboring cells to form bone within the graft materials,(d) remodel itself into long-lasting bone, (e) facilitate easy placement to avoid morbidity, and (f) have predictable success rate. Alloplastic materials are recently used as bone substitute. They are biologically acceptable, allowing bone ingrowths and bone remodeling while maintaining volume. Additionally, alloplastic materials have several advantages, such as (a) the lack of required donor site, (b) ample supply, and (c) the nonexistence of disease transmission. OSTEON is one of the alloplastic materials composed of hydroxyapatite (HA) 70% and beta-tricalcium phosphate ( -TCP) 30% which are most close to major mineral components of human bone, and have interconnected porosity structure (scaffolding) which is similar to that of human cancellous bone. Human bone OSTEON Figure 1. SEM morphology of OSTEON with interconnected pore structure (x120). The pore size is from 300 to 500, which is similar to human cancellous bone and the porous bone graft is beneficial to osteoblast cell ingrowth to OSTEON

22 22 Regeneration Bone Grafting & Soft Tissue Management Kim et al., J. Biomed. Mat. Res. B (2008) Figure 2. Cross-section view of OSTEON (left, x1000) and high magnification of OSTEON surface (right, x3000). The interconnected porous scaffold is comprised from biocompatible HA,while the surface is coated with bioresorbable -TCP. Purpose The objective of this study was to clinically evaluate the use of OSTEON as a sinus graft material and to measure the effect of healing at 4 and 6 months after surgery. Materials and Methods The two different commercially available OSTEON grafting materials (one with particle size of mm and the other with particle size of mm) were mixed in a ratio of 1:1, hydrated, followed by mixing with 10% autogenous bone chips and stabilized with tissue adhesive. After sinus graft (Fig. 3) using OSTEON in 17 patients, bone specimens were collected from lateral sinus using 2.0-mm trephine bur at the time of 4 or 6 months after surgery. Histology of the bone specimens was prepared and the percentage of newly formed bone fraction, lamellar bone/woven bone ratio (LB/WB), and newly formed bone/graft material ratio (NB/GM) were measured to indicate the suitability of the materials and the successful healing of the graft. Figure 3. The window-forming bone was pushed-on to make the upper border of the graft site, and sinus membrane was elevated carefully. Panorama X-ray images before surgery Panorama X-ray images 7 month after surgery Results & Discussions. The morphology of OSTEON was observed to be interconnected, with 77% porosity and a pore size of This observed architecture was suggested to be similar to human cancellous bone, with the interconnected porosity and pore size capable of providing space for bone cell ingrowth (Fig.1).After implantation, the mean percentage of newly formed bone fraction after 4 months and 6 months surgery was 40.6 and 51.9%, respectively (Table II). Statistical analysis indicated no significant difference (p = 0.135) in the newly formed bone fraction between the two postoperative periods.

23 Regeneration Bone Grafting & Soft Tissue Management 23 Kim et al., J. Biomed. Mat. Res. B (2008) As described in Table II, the mean LB/WB ratio after 4 months and 6 months surgery was 0.14 and 0.45, respectively, with significant difference observed between the two postoperative periods (p = 0.027). Additionally, the mean NB / GM ratio after 4 months and 6 months surgery was 1.95 and 7.72, respectively, with significant difference observed between the two postoperative periods (p = 0.046). Like most commercially available xenogenic and alloplastic bone grafting materials, bone healing during sinus graft applications using OSTEON is induced via osteoconduction. The host osteoprogenitor and angiogenic cells use the graft as a scaffold to generate new bone across the defect. As the host cells differentiate and mature within the graft, a functional skeletal network develops and replaces the graft through a creeping substitution process. The reported survival rates for grafted xenografts and alloplastic materials are equivalent or better than the survival rates for grafted autogenous materials. Additionally, these studies also indicated that the nonresorbed residual graft materials did not hinder osseointegration but significantly increase the bony density. Caution has to be taken on the mesial side of the sinus wall as the graft material is pressed against it. Too much pressure against the mesial side of the sinus wall causes small particles to obstruct new blood vessel formation and delayed resorbing large particles to retard the formation of new bone. Figure 4. Thickened, focally lamellar trabecular bone (closed asterisks) is seen around the resorbing implant material (open asterisks). H&E staining x40 (after 6 months) Summary and Conclusion In this study, OSTEON, a new alloplastic material was clinically evaluated as a sinus graft material. The morphology was observed to be interconnected, with 77% porosity and a pore size of 300~500 No significant difference in the percentage of newly formed bone fraction was observed at 4 months and 6 months after grafting in 17 patients. However, significant differences in mean LB / WB ratio and the mean NB / GM ratio were observed after 4 months and 6 months surgery. As confirmed by observations using the SEM, bone biopsy indicated more lamellar bone after 6 months surgery as compared to biopsy obtained after 4 months surgery. In this short-term study, it was concluded that OSTEON is suitable for use in sinus graft application since desirable time-dependent healing was demonstrated. For full report, please contact DENTIUM website

24 24 Regeneration Bone Grafting & Soft Tissue Management Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107: Analysis of the healing process in sinus bone grafting using various grafting materials Young-Kyun Kim, DDS, PhD, a Pil-Young Yun, DDS, PhD, a Su-Gwan Kim, DDS, PhD, b and Sung-Chul Lim, MD, PhD c SeongNam and GwangJu City, Korea SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL AND CHOSUN UNIVERSITY Objectives The purpose of this study was to compare differences in the healing process in the sinus bone grafting using various grafting materials. Study design Maxillary sinus bone grafts were divided into 4 groups according to the graft material used: group I, amixture of autogenous bone and BioOss (Osteohealth Co., Shirley, NY); group II, a mixture of BioOss and Orthoblast II (Greencross; Isotis); group III, BioOss only; and group IV, synthetic bone, Osteon (Genoss, Korea), only. To evaluate the healing status of the graft surgery, bone specimens were collected from the lateral sinus using a 2.0-mm trephine bur at 4 and 6 months after surgery. Histology of the bone specimens was prepared, and the percentage of newly formed bone fraction, lamellar bone/woven bone ratio (LB/WB), and newly formed bone/graft material ratio (NB/GM) were measured to indicate the suitability of the materials and the healing of the grafts. Results The LB / WB ratio and NB / GM ratio were markedly increased at 6 months compared with the values at 4months. It was observed that good bone healing was achieved even for grafts of xenogeneic bone only or synthetic bone only. Cases grafted with a mixture of allogeneic and xenogeneic bone showed no great advantage regarding bone healing. Table 1. Summary of the histomorphometric study Conclusion The results indicated that grafts of xenogeneic or synthetic bone can be effective for sinus bone grafting. I. Autogenous bone+biooss II. BioOSS +Orthoblast II III. BioOSS IV. OSTEON 4 month 6 month

25 Regeneration Bone Grafting & Soft Tissue Management 25 Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2010;109:e14-e20 Sinus bone graft using new alloplastic bone graft material(osteon) II : clinical evaluation Ji-Hyun Bae, DDS, PhD, a Young-Kyun Kim, DDS, PhD, b Su-Gwan Kim, DDS, PhD, c Pil-Young Yun, DDS, PhD, d and Jae-Seung Kim, DDS, PhD, e Seongnam, Gwangju, and Seoul, Korea SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL, CHOSUN UNIVERSITY, AND GUNGUK UNIVERSITY Objectives The objective of this study was to clinically evaluate the use of Osteon as a sinus bone graft material and to measure the loss of sinus bone graft volume and marginal bone loss around the implants. Study design Thirty-two implants were placed in 16 patients after maxillary sinus bone grafting. In 7 patients,maxillary sinus bone graft was performed first and 15 implants were placed after 4 months; in 9 patients, 17implants were placed simultaneously with maxillary sinus bone grafting. Based on medical records and radiographs, intraoperative and postoperative complications were examined, and at 1 year after the placement of the upper fixture,the success rate of implants, peri-implant soft tissue condition, and the marginal bone loss were evaluated. Additionally, the sinus bone graft volume loss was evaluated by comparing the residual alveolar bone height of the preoperative maxillary sinus floor with that immediately after the operation and after 1 year. Results Regarding intraoperative complications, perforation of the maxillary sinus membrane occurred in 6 cases (37.5%), and after surgery maxillary sinusitis developed in 2 cases. During the healing period, 1 implant failed in osseointegration. At the last follow-up observation, none of cases showed marginal bone loss of >1 mm and a 96.9% success rate was seen. The follow-up observation period after placement of the superstructure was months (average 15). Between the simultaneous placement group and the delayed placement group, marginal bone loss showed no statistically significant difference (P=.455). In the entire patient group, the volume of sinus bone graft loss did not correlate with marginal bone loss (P=.568). Preoperative alveolar bone height was mm (mean 4.64), postoperative alveolar bone height was mm (mean 17.67), and the alveolar bone height 1 year after the operation was mm (mean 16.78). Between the group with perforation of the maxillary sinus membrane and the group without, no difference in marginal bone loss was observed (P=.628). Additionally, no difference in the volume of sinus bone graft resorption between the two groups was observed (P=.970). Conclusion: It was concluded that Osteon is suitable for use in sinus graft application.

26 26 Regeneration Bone Grafting & Soft Tissue Management Tissue Engineering Regenerative Medicine, Vol.6, pp , Seoul, Korea, Mar.,2009. Effects of 4 Different Alloplastic Materials on Bone Regeneration in Rabbit Calvarial Defects Sun-Jong Kim 1,2, Jin-Won Lim 1, Jae-Jun Ryu 1,2, Jin-Soo Ahn 1,2, In-ho Han 2 and Sang-Wan Shin 1,2 * 1 Dept of Advan Prosthodontics, Graduate School of Clinical Dentistry, 2 Instit Clinical Dental Research, Korea Univ, 80, Guro-Gu, Seoul , Korea (Received: Jan. 2nd, 2009; Accepted: Jan. 7th, 2009) Objectives The purpose of this study was to compare bone regeneration in 8-mm defects in 8 New Zealand White rabbit calvaria using 4 different alloplastic bone substitutes. Materials and Methods Four 8-mm calvarial defects were made in the parietal bone of each animal. The defects were filled with BongrosHA (Bioalpha, Seongnam, Korea), micro macroporous biphasic calcium phosphate(mbcp, Biomatlante, France), Osteon (Dentium Co, Seoul, Korea) and Cerasorb (Curasan, Kleinsthei, Germany). Two animals died after surgery. Two rabbits were sacrificed after 4 weeks, and the other 4 were sacrificed after 8 weeks. Data analysis included the qualitative assessment of the calvarial specimens. Results and Discussion: Histomorphometric analysis was performed to quantify the amount of new bone within the defects. It was found that Osteon -treated defects had significantly more new bone after 8 weeks than all other groups. Osteon was an effective alloplastic bone substitute which showed reliable osseous healing of critical size defects in the rabbit calvarium. Conclusion: From the results of this study, it is suggested that HA and TCP alloplastic materials can be good bone substitutes for inducing new bone formation in rabbit calvaria in the early stage and that HA coated with TCP may have a better bone regeneration ability than HA, TCP or a mixture of HA and TCP. KEY WORDS: Bongros-HA, MBCP, Osteon, Cerasorb, critical size defect, rabbit model Table 1. For groups of alloplastic materials used in this study. Figure 1. Four different alloplastic materials were placed in the each defect.

27 Regeneration Bone Grafting & Soft Tissue Management 27 Tissue Engineering Regenerative Medicine, Vol.6, pp , Seoul, Korea, Mar.,2009. (a) (b) (c) (d) Figure 2. Histologic finding at 4 weeks after healing (x12).(a) BongrosHA, (b) MBCP, (c) Osteon and (d) Cerasorb (a) (b) (c) (d) Figure 3. Histologic finding 8 weeks after healing(x12). (a)bongrosha, (b)mbcp, (c)osteon and (d)cerasorb. Figure 4. Histomorphometric measurement of the percentages of newly formed bone. *p<0.05

28 28 Regeneration Bone Grafting & Soft Tissue Management J Periodontal Implant Sci 2011;41: doi: /jpis Case series of maxillary sinus augmentation with biphasic calcium phosphate: a clinical and radiographic study Jae-Kook Cha, Jung-Chul Park, Ui-Won Jung, Chang-Sung Kim, Kyoo-Sung Cho, Seong-Ho Choi* Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul, Korea Purpose The aim of this study was to evaluate 3.5 years-cumulative survival rate of implants placed on augmented sinus using Osteon, a bone graft material, and to assess the height of the grafted material through radiographic evaluation. Methods Twenty patients were treated with maxillary sinus augmentation and 45 implant fixtures were installed simultaneously or after 6 months healing period. The height of the augmented sinus and the loss of marginal bone were measured by panoramic and intraoral radiographs immediately after augmentation and up to 42 months (mean, 19.4 months) subsequently. Changes in the height of the sinus graft material were calculated radiographically. Results The cumulative survival rate was 95.56% in all 45 implants. Additionally, normal healing process without any complication was observed in all patients. The original sinus height was mean 4.3 mm and the augmented sinus height was mean13.4 mm after the surgery. The mean marginal bone loss till 42 months was 0.52±0.56 mm. The reduced height of Osteon was 0.83±0.38 mm and it did not show significant correlation with the follow up periods (P=0.102). There were no statistically significant differences in reduced height of Osteon according to the simultaneous/delayed implantation (P=0.299) and particle size of Osteon (P=0.644). Conclusions It can be suggested that Osteon may have predictable result when it was used as a grafting material for sinus floor augmentation. Keywords Dental implants, Maxillary sinus, Survival rate. Introduction. One of the necessary requirements for a dental implant is the presence of at least a moderate amount of bone in order to place an implant with the appropriate length and diameter. The loss of the alveolar ridge due to trauma, periodontal disease, or the failure of endodontic treatment, however, may make it difficult to place the implant in the best location for proper esthetics and function. The maxillary posterior area, is known to be especially difficult for implant treatment and to have a low success rate because of the poor bone quality. Moreover, the posterior edentulous maxilla has represented a challenge for clinicians owing to the resorption of the alveolar ridge and pneumatization of the maxillary sinus. This has led to the development of a bone augmentation technique, the onlay bone graft and sinus augmentation. Sinus augmentation via lateral window osteotomy has been routinely performed in the last few years and has been regarded as a predictable procedure [1-4]. However, the choice of the bone graft material is still under discussion. The use of autogenous bone in sinus augmentation has been regarded as a superior method because of the reproducible healing mechanism of osteogenesis, osteoinduction, and osteoconduction. Nevertheless, there are some limitations, e.g., the need for additional surgical sites and the rapid resorption rate when the autogenous bone is used as a sinus grafting material [5-7]. Therefore, the use of synthetic bone has been recently appraised for its biocompatibility and volume maintenance capacity [8,9]. Various synthetic materials have been developed for use in maxillary sinus augmentation to allow bone ingrowth and to prevent sinus pneumatization after grafting. Among them, the mixture of hydroxiapitite (HA) and beta-tricalcium phosphate ( -TCP) has been studied extensively as a new alloplastic material [10]. HA can play an osteoconductive role due to its appropriate space maintenance capacity, but it has a low-grade osteogenetic property. On the other hand, -TCP, with its good biocompatibility, has been used as a substitute for autogenous bone [11,12]. In light of this, mixing adequate ratios

29 Regeneration Bone Grafting & Soft Tissue Management 29 J Periodontal Implant Sci 2011;41: doi: /jpis of HA and -TCP allows for controlling the resorption rate without distorting its the bone s osteoconductive property [13-15]. Osteon (Dentium, Seoul, Korea) is synthetic material containing 70% HA and 30% -TCP. It has a porous structure, which can accelerate new bone ingrowth and maturation (Fig. 1). Two different particle sizes of Osteon have been used ( mm and mm). In several previous studies, Osteon was regarded as a suitable sinus augmentation material based on histologic analysis [16]. Moreover, we have previously reported on the volume maintenance of grafted Osteon and implant success rate in a pilot study [17]. In that study, the grafted material was well maintained in the sinus and decreased slightly over 1 year (0.05 mm/month). It is suggested that Osteon may produce predictable results when it is used as a grafting material for sinus floor augmentation. The aim of the present study was to evaluate the cumulative survival rate (CSR) of implants placed in sinuses augmented with Osteon, and to assess the resorption rate of the grafted material radiographically with increased sample size and statistical power as an extension to our previous studies. 500 µm Figure 1. Scanning electron microscope image of Osteon. CASE DESCRIPTION This study was approved by the Institutional Review Board of Yonsei University College of Dentistry (Approval No ). A total 45 implants were placed in 20 maxillary sinuses of 20 patients (8 males, 12 females, mean age 57.2±11.3 years) with the condition of having under 5 mm of residual alveolar bone height, using a sinus augmentation technique via lateral window osteotomy [18]. All implants were maintained with at least 6 months of prosthetic loading time. Patients exclusion criteria were: 1) heavy smoking (more than 20 cigarettes per day), 2) a debilitating systemic disease such as uncontrolled diabetes mellitus 3) signs and symptoms of maxillary sinus disease, or 4) active periodontal disease involving the residual dentition. Five implants were from Branemark System-MKIII TiUnite (NobelBiocare AB, Gotenborg, Sweden); 12 implants were from Xive (Dentsply Friadent, Mannheim, Germany), 5 implants were from Astra (Astra Tech AB, Mölndal, Sweden), 6 implants were from Osstem GSII (Osstem Implant Co., Busan, Korea), and 17 implants were from Implantium (Dentium). Five implants had a machined surface; 29 implants had a sandblasted, large-grid and acid etched surface; and 11 implants had a resorbable blast media surface. All implants were placed in either one- or two-stage surgery. The timing of implantation was determined, depending on the primary stabilization of implants. In the two-stage approach, implantation was performed 6 months after the augmentation of the maxillary sinus. A mixture of 2 different types of Osteon in a 1:1 ratio was used in 10 patients, while only the larger particle size of during the surgical procedure [19]. Most of the examined subsinus ridges were composed of bone with poor quality (type III and IV). General information on each case is presented in Table 1. Surgical technique A modified Caldwell-Luc sinus augmentation was performed under local anesthesia (2% lidocaine hydrochloride epinephrine 1:100,000; Huons Co., Seoul, Korea) [20,21]. In brief, the surgical area was prepared via elevation of a full thickness muco-periosteal flap. Osteotomy was performed at the lateral surface of the sinus wall using a diamond round bur and piezoelectric device (Piezosurgery, Mectron Spa, Carasco Genova, Italy) and the sinus membrane was carefully lifted. The sinus cavity was then packed with Osteon, and the lateral window was covered by an absorbable sponge (Collatape, Zimmer Dental, Calsbad, CA, USA). The muco-periosteal flap was repositioned and sutured with absorbable suture material (Monosyn 4.0 Glyconate Monofilament, B. Braun Melsungen AG, Melsungen, Germany; Vicryl 5.0 Polylactim, Johnson & Johnson, New Brunswick, NJ, USA). The prosthodontic procedure was completed after a mean healing period of 6-12 months.

30 30 Regeneration Bone Grafting & Soft Tissue Management J Periodontal Implant Sci 2011;41: doi: /jpis Table 1. Case summary. Implant survival rate The 42 months cumulative survival rate for implants was evaluated using life table analysis [22]. The success criteria for implants presented by Buser et al. [23] was used. Radiographic analysis The radiographic analysis was performed by panoramic radiographs and intraoral radiographs using software (Starpacs, Infinitt Co., Seoul, Korea). All the values were calibrated precisely based on the length of the implant fixture, and these were double checked by a single investigator. At least 2 consecutive panoramic radiographs were taken--one immediately after the sinus augmentation, the other 1 year after the surgery. Additional radiographs were obtained every 6 to 12 months through the follow-up period. The linear measurements taken from radiographs were described below (Fig. 2). The original alveolar bone heights prior to the surgery [24], from the alveolar crest to the base of the sinus were measured (Table 1). The augmented sinus heights (ASH) were measured from the 1st bone to implant contact points to the base of the maxillary sinus, which was elevated with Osteon at the mesial and distal aspects of the implants. The volume of marginal bone loss (MBL) was obtained compared with the intraoral radiographs immediately taken after the surgery and 1 year postoperatively. The reduced height of Osteon (RHO) was calculated based on the changes in the ASH and MBL. Figure 2. Schematic drawing illustrating the linear measurements taken from radiographs. (A) Immediately after the sinus augmentation. (B) 1-year after the sinus augmentation. ASH (m): mesial augmented sinus height, ASH (d): distal augmented sinus height, OAH (m): mesial original alveolar bone height, OAH (d): distal original alveolar bone height, MBL: marginal bone loss, I: implant fixture length, C: crown length A B Statistical analysis The individual mean values were calculated. Differences in RHO according to the timing of implantation and the type of Osteon were analyzed using a independent t-test. A one way analysis of variance was used to evaluate the difference in RHO according to the implant sites. A post-hoc Scheffe test was used to evaluate the differences between groups. A P value of <0.05 was considered significant. Correlation between the RHO and follow-up period were determined by Spearman s test. SPSS ver (SPSS Inc., Chicago, IL, USA) was used for all of the statistical analyses. Implant survival rate No complications, including wound dehiscence and sinus membrane perforation, were observed in any of the patients. Two of the 45 implants were removed between implantation and the follow up period (case 2, I16, 17). All loss of implants occurred prior to prosthetic loading. Both cases were successfully restored by wider diameter implants. The 0 to 6 month CSR was 95.56%, and this value continues to 42 months (Table 2).

31 Regeneration Bone Grafting & Soft Tissue Management 31 J Periodontal Implant Sci 2011;41: doi: /jpis Radiographic results The mean follow up period for implants after the sinus augmentation was 19.4 months (range, 12 to 42 months). The original sinus height was a mean of 4.3 mm (range, 2.5 to 5.8 mm) and the augmented sinus height was a mean of 13.4 mm (range, 9.81 to 18.1 mm) after the surgery. The mean crown/implant ratio was 1.19±0.24 mm which was relatively higher than the natural molar. The marginal bone loss up to 12months was measured as 0.29±0.42 mm and up to 42 months as 0.52±0.56 mm. The RHO 1 year postoperatively was 0.83±0.38 mm, and at 42 months postoperatively was 0.88±0.39 mm (Table 3). No significant correlation was noted between the RHO and follow up periods by Spearman s test (P=0.102). There were no statistically significant differences in the reduced height of Osteon depnding on simultaneous or delayed implantation (P=0.299; Table 4) and particle size of the Osteon (P=0.644; Table 5). In addition, no significant difference in the RHO was observed according to the site of implantation (P=0.527; Table 6). Table 2. Life table analysis. Table 4. Differences according to the timing of implantation (mean±sd). Table 5. Differences according to the type of material (mean±sd). Table 3. Radiographic analysis (mean±sd). Table 6. Differences according to the site of implants (mean±sd).). DISCUSSION An ideal material for maxillary sinus augmentation should provide biocompatibility to allow bone ingrowth and have a space maintaining property to prevent sinus pneumatization [24]. In the results of the present study, the grafted Osteon was well maintained in the sinus and decreased slightly over a 3.5-year time period, demonstrating that it is a clinically suitable material for sinus augmentation. Some volumetric loss of grafted material is unavoidable because of the air pressure from respiration in the maxillary sinus regardless of the type of material used [2,25,26]. Therefore, the change in the height of the grafted material is an important factor for implant stability. Previous studies about the loss of grafted material have been mixed. Hatano et al. [27] used autogenous bone and xenogenous bone mixed at a ratio of 2:1 for sinus augmentation with simultaneous implant placement and evaluated the resorption rate. They reported that statistically significant resorption had occurred after 2-3 years, and the maxillary sinus floor was observed at a similar level or slightly below that of the implant apex. On the other hand, Maiorana et al. [28] evaluated the resorption rate after 4 years of maxillary sinus augaugmentation using synthetic bone graft material (hydroxyapatite and collagen). The survival of implants was 97% and the grafted material remained steady, showing a mm resorption height. Generally, it was reported that the resorption rate is influenced by the type of graft material [2]. The resorption rate was 1.76 mm in autograft, 2.09 mm in allograft (freeze-dried demineralized bone), and 0.96 mm in alloplast (hydroxyapitite). The maxillary sinus cavity is a kind of contained defect surrounded by sinus basal bone and the Schneiderian membrane; thus it has excellent healing potential even without bone graft materials. From this perspective, the long-lasting synthetic and xenogenic bone materials are considered to be a better choice in terms of material resorption. Two out of 45 implants were removed in this study before prosthetic loading, so this can be regarded as an early failure. It seems that excessive hematoma causes the formation of exuberant granulation tissue, which can be detrimental to initial osseointegration. The overall CSR was 95.56%, and this result was comparable with other studies despite the small sample

32 32 Regeneration Bone Grafting & Soft Tissue Management J Periodontal Implant Sci 2011;41: doi: /jpis size [1-4]. The reduction in volume of the Osteon was higher than in our previous report (0.48 mm resorption in 13 months) [17]. No significant difference in the reduced volume of the Osteon was observed according to the timing of implantation. From our previous studies, it was reported that the largest amount of Osteon resorption occurred in the 1st molar area and the augmented sinus membrane was changed from a convex shape to a flat shape. In this study, however, there was no correlation between the area of the implantation and the resorption rate. Interestingly, the resorption of Osteon occurred regardless of the flow of time. In most other papers, it was found that the graft materials might undergo gradual resorption and pneumatization by time [2,27]. Hieu et al. [29] radiographically evaluated the changes in height of the xenogenic materials (Bio-Oss, Geistlich Sons, Wolhusen, Switzerland; OCS-B, Ni-bec, Seoul, Korea) after maxillary sinus augmentation over the course of 2 years. This study reported that significant material resorption can take place over time. Nonetheless, it could be assumed that many other factors, e.g., the air pressure in the maxillary sinus, the form of augmented material, and the density of the grafted material, are more important than the time flow. Therefore, it is possible that the resorption rate of the grafted material is affected by the host s environment. This would be expected to be clarified with further study. Two dimensional panoramic radiographs have been used to evaluate the grafted material and its relationship with implants [27,30,31]. Recently, a study utilizing computed-tomography and magnetic resonance imaging assessed the grafted sinus floor and this showed more accurate results on the volumetric change [32]. However, in the present study, we used only 2- dimensional images; thus further study using 3-dimensional images would provide a more accurate volumetric measurement of Osteon. Within the limitations of this study, it can be suggested that Osteon may have predictable results when it was used as a grafting material for sinus floor augmentation due to its excellent osteoconductive property. CONFLICT OF INTEREST No potential conflict of interest relevant to this article was reported. ACKNOWLEDGMENTS This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology (R ). REFERENCES 1. Chiapasco M, Zaniboni M, Rimondini L. Dental implants placed in grafted maxillary sinuses: a retrospective analysis of clinical outcome according to the initial clinical situation and a proposal of defect classification. Clin Oral Implants Res 2008;19: Jensen OT, Shulman LB, Block MS, Iacono VJ. Report of the Sinus Consensus Conference of Int J Oral Maxillofac Implants 1998;13 Suppl: Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol 2008;35(8 Suppl): Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol 2003;8: Hallman M, Hedin M, Sennerby L, Lundgren S. A prospective 1-year clinical and radiographic study of implants placed after maxillary sinus floor augmentation with bovine hydroxyapatite and autogenous bone. J Oral Maxillofac Surg 2002;60: Johansson B, Grepe A, Wannfors K, Hirsch JM. A clinical study of changes in the volume of bone grafts in the atrophic maxilla. Dentomaxillofac Radiol 2001;30: Misch CE, Dietsh F. Bone-grafting materials in implant dentistry. Implant Dent 1993;2: Dalky z M, Ozcan A, Yapar M, Gökay N, Yu ncu M. Evaluation of the effects of different biomaterials on bone defects. Implant Dent 2000;9: Kim YK, Yun PY, Kim SG, Lim SC. Analysis of the healing process in sinus bone grafting using various grafting materials. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107: Daculsi G, LeGeros RZ, Nery E, Lynch K, Kerebel B. Transformation of biphasic calcium phosphate ceramics in vivo : ultrastructural and physicochemical characterization. J Biomed Mater Res 1989;23: Gauthier O, Bouler JM, Aguado E, Pilet P, Daculsi G. Macroporous biphasic calcium phosphate ceramics: influence of macropore diameter and macroporosity percentage on bone ingrowth. Biomaterials 1998;19: Karabuda C, Ozdemir O, Tosun T, Anil A, Olgaç V. Histological and clinical evaluation of 3 different grafting materials for sinus lifting procedure based on 8 cases. J Periodontol 2001;72:

33 Regeneration Bone Grafting & Soft Tissue Management 33 J Periodontal Implant Sci 2011;41: doi: /jpis Nery EB, LeGeros RZ, Lynch KL, Lee K. Tissue response to biphasic calcium phosphate ceramic with different ratios of HA/beta TCP in periodontal osseous defects. J Periodontol 1992;63: Yamada S, Heymann D, Bouler JM, Daculsi G. Osteoclastic resorption of biphasic calcium phosphate ceramic in vitro. J Biomed Mater Res 1997;37: Yamada S, Heymann D, Bouler JM, Daculsi G. Osteoclastic resorption of calcium phosphate ceramics with different hydroxyapatite/beta-tricalcium phosphate ratios. Biomaterials 1997;18: Kim YK, Yun PY, Lim SC, Kim SG, Lee HJ, Ong JL. Clinical evaluations of OSTEON as a new alloplastic material in sinus bone grafting and its effect on bone healing. J Biomed Mater Res B Appl Biomater 2008;86: Lee JH, Jung UW, Kim CS, Choi SH, Cho KS. Maxillary sinus augmentation using macroporous biphasic calcium phosphate (MBCP(TM)): three case report with histologic evaluation. J Korean Acad Periodontol 2006;36: Zitzmann NU, Schärer P. Sinus elevation procedures in the resorbed posterior maxilla. Comparison of the crestal and lateral approaches. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1998;85: Zarb GA, Zarb FL. Tissue integrated dental prostheses. Quintessence Int 1985;16: Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg 1980;38: Kent JN, Block MS. Simultaneous maxillary sinus floor bone grafting and placement of hydroxylapatite-coated implants. J Oral Maxillofac Surg 1989;47: Cutler SJ, Ederer F. Maximum utilization of the life table method in analyzing survival. J Chronic Dis 1958;8: Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res 1990;1: Block MS, Kent JN, Kallukaran FU, Thunthy K, Weinberg R. Bone maintenance 5 to 10 years after sinus grafting. J Oral Maxillofac Surg 1998;56: Chanavaz M. Maxillary sinus: anatomy, physiology, surgery, and bone grafting related to implantology--eleven years of surgical experience ( ). J Oral Implantol 1990;16: Chanavaz M, Francke JP, Donazzan M. The maxillary sinus and implantology. Chir Dent Fr 1990;60: Hatano N, Shimizu Y, Ooya K. A clinical long-term radiographic evaluation of graft height changes after maxillary sinus floor augmentation with a 2:1 autogenous bone/xenograft mixture and simultaneous placement of dental implants. Clin Oral Implants Res 2004;15: Maiorana C, Sigurtà D, Mirandola A, Garlini G, Santoro F. Sinus elevation with alloplasts or xenogenic materials and implants: an up-to-4-year clinical and radiologic follow-up. Int J Oral Maxillofac Implants 2006;21: Hieu PD, Chung JH, Yim SB, Hong KS. A radiographical study on the changes in height of grafting materials after sinus lift: a comparison between two types of xenogenic materials. J Periodontal Implant Sci 2010;40: Kahnberg KE, Ekestubbe A, Gröndahl K, Nilsson P, Hirsch JM. Sinus lifting procedure. I. One-stage surgery with bone transplant and implants. Clin Oral Implants Res 2001;12: Keller EE, Eckert SE, Tolman DE. Maxillary antral and nasal one-stage inlay composite bone graft: preliminary report on 30 recipient sites. J Oral Maxillofac Surg 1994;52: Gray CF, Redpath TW, Bainton R, Smith FW. Magnetic resonance imaging assessment of a sinus lift operation using reoxidised cellulose (Surgicel) as graft material. Clin Oral Implants Res 2001;12:

34 26 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM II

35 Regeneration Bone Grafting & Soft Tissue Management OSTEON TM Collagen / OSTEON TM Collagen / OSTEON TM (Sinus&Lifting)/OSTEON TM (Sinus&Lifting) ORTHOPEDIC OSTEON TM / OSTEOGuide TM Collagen Membrane / HA Collagen Membrane Copyright June, 2012 DENTIUM

36 Regeneration Bone Grafting & Soft Tissue Management Specifications are subject to change without prior notice. Some products to be launched in the market after necessary approvals are also listed in this catalog. HEAD OFFICE 3105 Trade Tower 159, Samsung-dong, Gangnam-gu, Seoul, Korea T F CAT-B0401(REV.18,1206 MANUFACTURER 1F, Gyeonggi R&DB Center / 226, 2F, GSBC Iui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, , Korea T F HOMEPAGE /