Regeneration - · PDF fileORTHOPEDIC OSTEONTM 14 Regeneration Bone Grafting & Soft Tissue...

RegenerationBone Grafting & Soft Tissue Management

OSTEONTM

Bone Graft MaterialOSTEONTM II Collagen 04OSTEONTM Collagen 06OSTEONTM II (Sinus & Lifting) 08OSTEONTM (Sinus & Lifting) 12ORTHOPEDIC OSTEONTM 14

MembraneOSTEOGuideTM 15

Collagen Membrane 16

HA Collagen Membrane 18

Documentation SummariesBone 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 inRabbit Calvarial Defects 26

Case series of maxillary sinus augmentation with biphasic calcium phosphate: a clinical and radiographic study 28

Table of Contents

OSTEONTM Il Collagen

04 Regeneration Bone Grafting & Soft Tissue Management

Application of OSTEONTM II Collagen

• Simple grafting (volume up)• Ridge augmentation• Extraction site & osteotomy• Cystic cavities• Periodontal defect

Characteristics of OSTEONTM II Collagen• Bone void filler composed of synthetic bonegraft(OSTEONTM II) and natural type I collagen• Moldable to various defect shape after being wet• Easy handling, thus shortened operation time• OSTEONTM 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 OSTEONTM II

Animal Test

• Animals : New Zealand white rabbit

• Implantation Area : Femur

• Period : 6 weeks

• CT image

05Regeneration Bone Grafting & Soft Tissue Management

Products

Type REF Size Particle Size (mm)

Cylinder 0.2~0.5 mmOTCC0605S Ø6.0 x 5.0 mm

OTCC0610S Ø6.0 x 10.0 mm

Clinical Case

Ridge augmentation

GBR


Application of OSTEONTM Collagen

• Ridge augmentation• Extraction site & osteotomy• Cystic cavities• Sinus lift• Periodontal defect

Description

OSTEONTM Collagen is a bone void filler composed of synthetic bone(OSTEONTM),

and natural type I collagen.

Characteristics of OSTEONTM 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 OSTEONTM Collagen

OSTEONTM Collagen

X 1000 X 5000


1. Animals: new zealand white rabbit2. Implantation area: calvaria3. Period: 8 weeks4. Staining method: goldner trichrome

8 weeks

Animal Test

Clinical Case

Products

Type REF Size (mm) Particle Size (mm)

CylinderGOCC0605 Ø6.0 x 5.0

GOCC0610 Ø6.0 x 10.0

Ridge augmentation

Full mouth rehabilitation

Ridge preservation

0.5 ~ 1.0

OSTEONTM II (Sinus & Lifting)


Application of OSTEONTM II

• Ridge augmentation• Extraction site & osteotomy• Cystic cavities• Sinus lift• Periodontal defect

Composition of OSTEONTM II

Osteoconductive biphasic calcium phosphate with higher -TCP

OSTEONTM II = HA 30% + -TCP 70%

Characteristics of OSTEONTM II• Highly resorbable due to higher -TCP content • Easy manipulation• Excellent wettability • Osteoconductive synthetic bonegraft • Pore size : 250• Porosity : 70%

Cell Adhesion TestOsteoblasts attached & spreaded well

In Vitro Dissolution Test


OSTEONTM OSTEONTM II

Animal Test12-weeks follow up in rabbit calvaria model

Products

Type REF Volume (cc) Particle Size (mm)

Vial

DT7G0205025 0.25

DT7G0205050 0.5

DT7G0205100 1.0

0.2~0.5

DT7G0510025 0.25

DT7G0510050 0.5

DT7G0510100 1.0

DT7G1020025 0.25

DT7G1020050 0.5

DT7G1020100 1.0

0.5~1.0

1.0~2.0

Sinus

Lifting

0.5~1.0

1.0~2.0

0.2~0.5

0.5~1.0

DT7G0510050SS 0.5

DT7G1020050SS 0.5

DT7G0205025LS 0.25

DT7G0510025LS 0.25

Clinical Case

GBR

OSTEONTM

Human osteoblast cell

OSTEONTM(Sinus & Lifting)


Application of OSTEONTM

• Ridge augmentation• Extraction site• Cystic cavities• Sinus lift• Periodontal defect

Composition of OSTEONTM

100% Synthetic bone graft : HA scaffold coated with -TCP

OSTEONTM = HA 70% + -TCP 30%

Specification of OSTEONTM

• 100% synthetic bone graft• Interconnected porous structure similar to that of human cancellous bone• Osteoconductive material as a bone growth scaffold

OSTEONTM Human bone

Cell Adhesion Test

X 1000 X 1000 X 5000

Osteoblast cell was well attached and spreaded on OSTEONTM surface.

New bone


Human Histology

OSTEONTM area = 1.24mm2 (17.1%)New bone area = 1.63mm2 (22.7%)

6.5 months after sinus graft surgery


21 months after sinus graft surgery


10 months after sinus graft surgery

0.5mm 0.25mm

1.0mm

0.5mm 0.25mm

1.5mm

OSTEONTM

New bone

OSTEONTM

New bone

OSTEONTM


Product REF Particle Size (mm) Volume (cc)

Vial

GBG0305 0.3~0.5

GBG1020 1.0~2.0

GBG0510 0.5~1.0 0.25 / 0.5 / 1.0

Product O.D. I.D.

OSTEONTM Sinus Ø7.0mm Ø5.0mm

Ø5.0mm Ø3.4mm

Sinus

GBG0510SS 0.5~1.0

GBG1020SS 1.0~2.0

0.5

Lifting

GBG0305LS 0.3~0.5

GBG0510LS 0.5~1.0

0.25

Products

Syringe

OSTEONTM Lifting

O.D. : syringe outer diameter

I.D. : syringe inner diameter


Slightly retract the plunger andgently tap to loosen particles.Gently push plunger back intoplace.

Place syringe into a steriledappen dish and retract plungerto draw liquid into the syringe.

To optimize delivery, OSTEONTM

should be wetted and loosenedsufficiently.

When sufficiently hydrated,OSTEONTM will expel with easefrom the syringe. Before injectingOSTEONTM, remove the cap fromthe syringe.

Deliver OSTEONTM directlyinto the surgical site withthe syringe.

Instruction for OSTEONTM Sinus & Lifting

Expel excess liquid by applyingvery gentle pressure on theplunger.

Clinical Case

After 9 months

OSTEONTM Sinus case(Sinus grafting - lateral approach)

OSTEONTM Lifting case(Sinus grafting - crestal approach)

ORTHOPEDIC OSTEONTM


Application of ORTHOPEDIC OSTEONTM

• Bone filling• Fractures with bone defects• Pseudoarthrosis with or without bone defects• Tibial osteotomy• In certain cases of arthroplasty revision

GOBG0510, GOBG1020, GOBG2030, GOBG3040, GOBG4050 are available.

Product REF Particle Size (mm) Volume (cc)

ORTHOPEDIC OSTEON™

GOBG2040 2.0~4.0

GOBG4070 4.0~7.0

3.0 / 4.0 / 5.0 /

10.0 / 15.0 / 20.0

Products

• 12 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 OSTEONTM .

Animal Test - Rabbit Femur Model

X 12.5 X 100

Clinical CaseBone void filler

OSTEOGuideTM


Description

• Non-resorbable GBR membrane• Biocompatible polymer PCL• Thin for easy manipulation• Porous membrane

Product REF Size (mm) Thickness (mm)

OSTEOGuideTM

GPM1020 10 X 20

GPM2030 20 X 30

GPM3040 30 X 40

0.12

Products

OSTEOGuideTM

Soft tissue

Bio-compatible polymer = 100% PCL (Polycaprolactone)

• The porous outer surface of the OSTEOGuideTM allowseasy entry of the adjacent cells assuring rapid and goodtissue attachment.

• Good nutrient flow and blood vessel formation supportedby the porous structure.

Animal test - rabbit calvaria model

• New bone was well formed on the bottom of theOSTEOGuideTM and cells did not penetrate into the defect.

Composition of OSTEOGuideTM

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 strengthin 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


Preclinical Data

• Rabbit calvaria bodel, 6 -12 weeks

6 weeks

12 weeks

• Degradation character in collagenase solution


Collagen

Membrane

GCM1020 10 X 20

GCM1520 15 X 20

GCM2030 20 X 30

0.3

Products

Clinical Case GBR

GBR


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

X 500

Microstructure

X 100 X 70000

MC3T3 / E1 (Osteoblast cell)


Animal TestRabbit calvaria model, 12 weeks


HA Collagen

Membrane

GCHM 1020 10 X 20

GCHM 1520 15 X 20

GCHM 2030 20 X 30

0.3

Products

Clinical CaseGBR

Socket preservation


Bone Graft Material

Documentation Summaries

Interconnected Pore


This is the summary of Clinical Evaluations OSTEON as a New Alloplastic Material in Sinus Bone Graftingand its effects on Bone Healing” which is published at Journal of Biomedical Material Research Part B, written byProf. Young-Kyun Kim.

Introduction.Placement of implant prosthesis in the maxillary posterior region is known to be difficult on many aspects and has lowestsuccess rate. In many clinical situations, the maxillary region is made of type III or IV bone with porous and insufficientbones for implant placement. The advancement in implant surgical techniques, improved bone graft, and recent developmentin implant surface treatments have resulted in predictable sinus bone graft success, thereby allowing implant placement inthe maxillary molar region.However, controversy still exists on what constitute an ideal sinus graft materials. Ideally, the bone graft material used forimplant 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-lastingbone, (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 andbone remodeling while maintaining volume. Additionally, alloplastic materials have several advantages, such as (a) thelack 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 (β-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 cancellousbone and the porous bone graft is beneficial to osteoblast cell ingrowth to OSTEON

Jounal of Biomedical Materials Research Part B. Applied Biomaterials. 2008. vol 86 page 270~277

Kim et al., J. Biomed. Mat. Res. B (2008)

Young-Kyun Kim,1 Pil-Young Yun,1 Sung-Chul Lim,2 Su-Gwan Kim,3 Hyo-Jung Lee,4

Joo L. Ong 5

Clinical Evaluation of OSTEON® as New Alloplastic Material in SinusBone Grafting and Effect on Bone Healing

Regeneration Bone Grafting & Soft Tissue Management22

Panorama X-ray images before surgery Panorama X-ray images 7 month after surgery

PurposeThe objective of this study was to clinically evaluate the use of OSTEON as a sinus graft material and to measure theeffect of healing at 4 and 6 months after surgery.

Materials and MethodsThe two different commercially available OSTEON grafting materials (one with particle size of 0.5-1.0 mm and the otherwith particle size of 1.0-2.0 mm) were mixed in a ratio of 1:1, hydrated, followed by mixing with 10% autogenous bonechips and stabilized with tissue adhesive. After sinus graft (Fig. 3) using OSTEON in 17 patients, bone specimens werecollected from lateral sinus using 2.0-mm trephine bur at the time of 4 or 6 months after surgery. Histology of the bonespecimens was prepared and the percentage of newly formed bone fraction, lamellar bone/woven bone ratio (LB/WB), andnewly formed bone/graft material ratio (NB/GM) were measured to indicate the suitability of the materials and the successfulhealing of the graft.

Figure 3. The window-forming bone was pushed-on to make the upper borderof the graft site, and sinus membrane was elevated carefully.

Figure 2. Cross-section view of OSTEON (left, x1000) and high magnificationof OSTEON surface (right, x3000). The interconnected porous scaffold is comprised from biocompatible HA,whilethe surface is coated with bioresorbable β-TCP.

The morphology of OSTEON was observed to be interconnected, with 77% porosity and a pore size of 300–500 . Thisobserved architecture was suggested to be similar to human cancellous bone, with the interconnected porosity and poresize capable of providing space for bone cell ingrowth (Fig.1).After implantation, the mean percentage of newly formedbone fraction after 4 months and 6 months surgery was 40.6 and 51.9%, respectively (Table II). Statistical analysis indicatedno significant difference (p = 0.135) in the newly formed bone fraction between the two postoperative periods.

Results & Discussions.



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 observedbetween the two postoperative periods (p = 0.046).Like most commercially available xenogenic and alloplastic bone grafting materials, bone healing during sinus graft applicationsusing OSTEON is induced via osteoconduction. The host osteoprogenitor and angiogenic cells use the graft as a scaffoldto generate new bone across the defect. As the host cells differentiate and mature within the graft, a functional skeletal networkdevelops and replaces the graft through a “creeping substitution” process. The reported survival rates for graftedxenografts 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 butsignificantly 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 pressureagainst the mesial side of the sinus wall causes small particles to obstruct new blood vessel formation and delayed resorbinglarge particles to retard the formation of new bone.

Figure 4. Thickened, focally lamellar trabecular bone (closed asterisks) is seen aroundthe resorbing implant material (open asterisks). H&E staining x40 (after 6 months)

Summary and ConclusionIn this study, OSTEON, a new alloplastic material was clinically evaluated as a sinus graft material. The morphology wasobserved to be interconnected, with 77% porosity and a pore size of 300~500 No significant difference in the percentageof newly formed bone fraction was observed at 4 months and 6 months after grafting in 17 patients. However, significantdifferences 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 comparedto biopsy obtained after 4 months surgery. In this short-term study, it was concluded that OSTEON is suitable for use insinus graft application since desirable time-dependent healing was demonstrated.

For full report, please contact DENTIUM website www.dentium.com



Young-Kyun Kim, DDS, PhD, a Pil-Young Yun, DDS, PhD, a Su-Gwan Kim, DDS, PhD, b andSung-Chul Lim, MD, PhD c SeongNam and GwangJu City, Korea

SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL AND CHOSUN UNIVERSITY

ObjectivesThe purpose of this study was to compare differences in the healing process in the sinus bone grafting using various graft-ing materials.

Study designMaxillary sinus bone grafts were divided into 4 groups according to the graft material used: group I, amixture of autogenousbone 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 ofthe graft surgery, bone specimens were collected from the lateral sinus using a 2.0-mm trephine bur at 4 and 6 monthsafter surgery. Histology of the bone specimens was prepared, and the percentage of newly formed bone fraction, lamellarbone/woven bone ratio (LB/WB), and newly formed bone/graft material ratio (NB/GM) were measured to indicate thesuitability of the materials and the healing of the grafts.

ResultsThe LB / WB ratio and NB / GM ratio were markedly increased at 6months compared with the values at 4months. It was observed thatgood bone healing was achieved even for grafts of xenogeneic boneonly or synthetic bone only. Cases grafted with a mixture of allogeneicand xenogeneic bone showed no great advantage regarding bonehealing.

ConclusionThe results indicated that grafts of xenogeneic or synthetic bone canbe effective for sinus bone grafting.

Table 1. Summary of the histomorphometric study

I. Autogenousbone+BioOSS

II. BioOSS+Orthoblast II III. BioOSS IV. OSTEON

4 month

6 month

Analysis of the healing process in sinus bone grafting using various grafting materials

Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107:204-211


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

ObjectivesThe objective of this study was to clinically evaluate the use of Osteon as a sinus bone graft material and to measure the loss ofsinus bone graft volume and marginal bone loss around the implants.

Study designThirty-two implants were placed in 16 patients after maxillary sinus bone grafting. In 7 patients,maxillary sinus bone graftwas performed first and 15 implants were placed after 4 months; in 9 patients, 17implants were placed simultaneouslywith maxillary sinus bone grafting. Based on medical records and radiographs, intraoperative and postoperative complicationswere examined, and at 1 year after the placement of the upper fixture,the success rate of implants, peri-implant soft tissuecondition, 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 preoperativemaxillary sinus floor with that immediately after the operation and after 1 year.

ResultsRegarding intraoperative complications, perforation of the maxillary sinus membrane occurred in 6 cases (37.5%), andafter 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 12-30 months (average 15). Between thesimultaneous placement group and the delayed placement group, marginal bone loss showed no statistically significantdifference (P= .455). In the entire patient group, the volume of sinus bone graft loss did not correlate with marginal boneloss (P= .568). Preoperative alveolar bone height was 0.8-8.8 mm (mean 4.64), postoperative alveolar bone height was 12-21.8 mm (mean 17.67), and the alveolar bone height 1 year after the operation was 11.2-20.8 mm (mean 16.78). Betweenthe group with perforation of the maxillary sinus membrane and the group without, no difference in marginal bone losswas observed (P= .628). Additionally, no difference in the volume of sinus bone graft resorption between the two groupswas observed (P= .970).

Conclusion:It was concluded that Osteon is suitable for use in sinus graft application.

Sinus bone graft using new alloplastic bone graft material(Osteon)—II: clinical evaluation

Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2010;109:e14-e20

Effects of 4 Different Alloplastic Materials on Bone Regeneration inRabbit Calvarial Defects


Sun-Jong Kim1,2 , Jin-Won Lim1 , Jae-Jun Ryu1,2 , Jin-Soo Ahn1,2 , In-ho Han2 and Sang-Wan Shin1,2 *

1 Dept of Advan Prosthodontics, Graduate School of Clinical Dentistry,2 Instit Clinical Dental Research, Korea Univ, 80, Guro-Gu, Seoul 152-703, Korea(Received: Jan. 2nd, 2009; Accepted: Jan. 7th, 2009)

ObjectivesThe purpose of this study was to compare bone regeneration in 8-mm defects in 8 New Zealand White rabbit calvariausing 4 different alloplastic bone substitutes.

Materials and MethodsFour 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 rabbitswere sacrificed after 4 weeks, and the other 4 were sacrificed after 8 weeks. Data analysis included the qualitative assessmentof the calvarial specimens.

Results and Discussion:Histomorphometric analysis was performed to quantify the amount of new bone within the defects. It was found thatOsteon™-treated defects had significantly more new bone after 8 weeks than all other groups. Osteon™ was aneffective 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 forinducing new bone formation in rabbit calvaria in the early stage and that HA coated with TCP may have a better boneregeneration ability than HA, TCP or a mixture of HA and TCP.

KEY WORDS: Bongros-HA™, MBCP ™, Osteon™, Cerasorb®, critical size defect, rabbit model

Figure 1. Four different alloplastic materials were placed in the each defect.

Table 1. For groups of alloplastic materials used in this study.

Tissue Engineering Regenerative Medicine, Vol.6, pp. 63-68, Seoul, Korea, Mar.,2009.


Tissue Engineering Regenerative Medicine, Vol.6, pp. 63-68, Seoul, Korea, Mar.,2009.

Figure 2. Histologic finding at 4 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

Figure 3. Histologic finding 8 weeks after healing(X12). (a)BongrosHA, (b)MBCP, (c)Osteon and (d)Cerasorb.

(a) (b)

(c) (d)

(a) (b)

(c) (d)


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

J Periodontal Implant Sci 2011;41:98-104 • doi: 10.5051/jpis.2011.41.2.98

PurposeThe aim of this study was to evaluate 3.5 years-cumulative survival rate of implants placed on augmented sinus usingOsteon, a bone graft material, and to assess the height of the grafted material through radiographic evaluation.

MethodsTwenty patients were treated with maxillary sinus augmentation and 45 implant fixtures were installed simultaneously orafter 6 months healing period. The height of the augmented sinus and the loss of marginal bone were measured bypanoramic 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.

ResultsThe cumulative survival rate was 95.56% in all 45 implants. Additionally, normal healing process without any complicationwas observed in all patients. The original sinus height was mean 4.3 mm and the augmented sinus height was mean13.4 mmafter the surgery. The mean marginal bone loss till 42 months was 0.52±0.56 mm. The reduced height of Osteon was 0.83±0.38mm and it did not show significant correlation with the follow up periods (P=0.102). There were no statistically significantdifferences in reduced height of Osteon according to the simultaneous/delayed implantation (P=0.299) and particlesize of Osteon (P=0.644).

ConclusionsIt can be suggested that Osteon may have predictable result when it was used as a grafting material for sinus floor augmentation.

KeywordsDental 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, orthe failure of endodontic treatment, however, may make it difficult to place the implant in the best location for properesthetics and function. The maxillary posterior area, is known to be especially difficult for implant treatment and to have alow success rate because of the poor bone quality. Moreover, the posterior edentulous maxilla has represented a challengefor 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 apredictable 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 graftingmaterial [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 itsappropriate space maintenance capacity, but it has a low-grade osteogenetic property. On the other hand, -TCP, with itsgood biocompatibility, has been used as a substitute for autogenous bone [11,12]. In light of this, mixing adequate ratios



CASE DESCRIPTIONThis study was approved by the Institutional Review Board of Yonsei University College of Dentistry (Approval No. 5-

2008-3). A total 45 implants were placed in 20 maxillary sinuses of 20 patients (8 males, 12 females, mean age 57.2±11.3years) with the condition of having under 5 mm of residual alveolar bone height, using a sinus augmentation technique vialateral 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 asuncontrolled diabetes mellitus 3) signs and symptoms of maxillary sinus disease, or 4) active periodontal disease involvingthe 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), 6implants 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 implantshad a resorbable blast media surface. All implants were placed in either one- or two-stage surgery. The timing of implantationwas determined, depending on the primary stabilization of implants. In the two-stage approach, implantation was performed6 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 dur-

ing the surgical procedure [19]. Most of the examined subsinus ridges were composed of bone with poor quality (type IIIand IV). General information on each case is presented in Table 1.

Surgical techniqueA 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 thicknessmuco-periosteal flap. Osteotomy was performed at the lateral surface of the sinus wall using a diamond round bur andpiezoelectric 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 6-12months.

of HA and -TCP allows for controlling the resorption ratewithout 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, whichcan accelerate new bone ingrowth and maturation (Fig. 1).Two different particle sizes of Osteon have been used (0.5-1.0 mm and 1.0-2.0 mm). In several previous studies, Osteonwas regarded as a suitable sinus augmentation material basedon histologic analysis [16]. Moreover, we have previouslyreported on the volume maintenance of grafted Osteon andimplant success rate in a pilot study [17]. In that study, thegrafted material was well maintained in the sinus anddecreased slightly over 1 year (0.05 mm/month). It is suggestedthat Osteon may produce predictable results when it is usedas 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 augmentedwith Osteon, and to assess the resorption rate of the graftedmaterial radiographically with increased sample size andstatistical power as an extension to our previous studies.

Figure 1. Scanning electron microscope image of Osteon.

500 µm


Implant survival rateThe 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 analysisThe 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 thesewere double checked by a single investigator. At least 2 consecutive panoramic radiographs were taken--one immediatelyafter the sinus augmentation, the other 1 year after the surgery. Additional radiographs were obtained every 6 to 12 monthsthrough 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 ofthe maxillary sinus, which was elevated with Osteon at the mesial and distal aspects of the implants. The volume of marginalbone loss (MBL) was obtained compared with the intraoral radiographs immediately taken after the surgery and 1 yearpostoperatively. The reduced height of Osteon (RHO) was calculated based on the changes in the ASH and MBL.

Statistical analysisThe 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 inRHO according to the implant sites. A post-hoc Scheffe test was used to evaluate the differences between groups. A P valueof <0.05 was considered significant. Correlation between the RHO and follow-up period were determined by Spearman’stest. SPSS ver. 12.0.0 (SPSS Inc., Chicago, IL, USA) was used for all of the statistical analyses.

Implant survival rateNo 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 implantsoccurred prior to prosthetic loading. Both cases were successfully restored by wider diameter implants. The 0 to 6 monthCSR was 95.56%, and this value continues to 42 months (Table 2).

Figure 2. Schematic drawing illustrating the linear measurements taken fromradiographs. (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 boneheight, OAH (d): distal original alveolar bone height, MBL: marginal boneloss, I: implant fixture length, C: crown length

A B

Table 1. Case summary.



Radiographic resultsThe 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 thenatural molar. The marginal bone loss up to 12months was measured as 0.29±0.42 mm and up to 42 months as 0.52±0.56mm. 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 wereno 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 RHOwas observed according to the site of implantation (P=0.527; Table 6).

DISCUSSIONAn 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 wellmaintained in the sinus and decreased slightly over a 3.5-year time period, demonstrating that it is a clinically suitablematerial 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 importantfactor 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 ata similar level or slightly below that of the implant apex. On the other hand, Maiorana et al. [28] evaluated the resorptionrate 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 0.5-1 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 inautograft, 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 syntheticand 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 initialosseointegration. The overall CSR was 95.56%, and this result was comparable with other studies despite the small sample

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 6. Differences according to the site of implants (mean±SD).).

Table 3. Radiographic analysis (mean±SD).



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 ourprevious studies, it was reported that the largest amount of Osteon resorption occurred in the 1st molar area and the augmentedsinus membrane was changed from a convex shape to a flat shape. In this study, however, there was no correlation between thearea 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 evaluatedthe 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 resorptioncan take place over time. Nonetheless, it could be assumed that many other factors, e.g., the air pressure in the maxillarysinus, 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 beexpected 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 sinusfloor 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 ofOsteon.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 INTERESTNo potential conflict of interest relevant to this article was reported.

ACKNOWLEDGMENTSThis 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 (R13-2003-013-04002-0).

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OSTEONTM II

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