DENT 655- Health Technology Assessment

A Health Technology Assessment Report on

Clinical Efficacy and Cost of Allograft use in

Maxillary Sinus Lift Procedure Performed

by the Lateral Window Technique

by

Vanita Krishnan a

with the expert assistance of

Shahrokh Esfandiarib

April 2013

Report No: S2013.03

a Masters candidate, Faculty of Dentistry, McGill University, Montreal, Canada

b Associate Professor, Division of Oral Health and Society, Faculty of Dentistry, McGill

University

For more information contact Dr. Shahrokh Esfandiari at shahrokh.esfandiari@mail.mcgill.ca

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The views expressed in this report are those of the author(s) and do not necessarily reflect the

views of the Faculty of Dentistry, McGill University. This report was developed for the course

„DENT 655- Health Technology Assessment‟ and assumes a call from general dentists to assist

decision-making in dental offices, clinical and hospitals. All are welcome to make use of it.

However, to help us estimate the impact, it would be deeply appreciated if users could inform us

whether it has influenced policy decisions in any way.

Suggested Citation: Krishnan, V. & Esfandiari, S. (2013). A Health Technology Assessment

Report on Clinical Efficacy and Cost of Allograft use in Maxillary Sinus Lift Procedure

Performed by the Lateral Window Technique (Report no: S2013.03). Montreal, Canada: Faculty

of Dentistry, McGill University. Retrieved from: https://www.mcgill.ca/dentistryohs/courses-

and-events/dent-655/hta-reports

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ACKNOWLEDGEMENTS:

The expert assistance of the following individuals is gratefully acknowledged:

• Mr. Martin Morris, Liason Librarian, Life Sciences Library, McGill University,

Montreal, Canada.

• Dr. Shahrokh Esfandiari, Assistant Professor, Faculty of Dentistry, Oral Health and

Society Research Unit, McGill University, Montreal, Canada.

• Dr. Mohammad Ahmad Javaid, M.Sc.Candidate, Faculty of Dentistry, McGill

University, Montreal, Canada.

• Dr. Akanksha Srivastava, M.Sc. Candidate, Faculty of Dentistry, McGill University,

Montreal, Canada.

• Mr. Michael McMillan, Vice President - Sales & Marketing, Citagenix Inc. ,Laval,

Canada.

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TABLE OF CONTENTS

Executive Summary 4

1. Background 7

2. Objective 14

3. Health Outcome 14

4. Methods 14

5. Results 16

6. Cost - Analysis 20

7. Conclusion 20

References 27

TABLES

1. Types of Bone Graft Materials 22

2. Basic Patient Data 23

3. Characteristics of Surgical Procedures 23

4. Summary of clinical efficacy of allografts 24

5. Comparative Studies 24

6. Weighted average of new bone formed using different graft materials 25

7. Weighted average of new bone formed using different types of allografts 25

8. Cost Summary 26

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EXECUTIVE SUMMARY

Background

Rehabilitation of edentulous posterior maxilla with endosseous implants has always proven to be

a challenge due to deficient ridge height attributable to pneumatization of maxillary sinus along

with resorption or loss of alveolar crestal bone. Therefore, procedures such as the maxillary sinus

elevation (lift) with bone augmentation are essential to increase the amount of vertical bone

height in the posterior maxilla for placement of implants. Various types of grafting materials

such as autografts, allografts, xenografts and synthetic bone substitutes have been successfully

used in sinus lifts, however, the question as to which material is the most appropriate for sinus

lifts is still a matter of debate.

Objective

The purpose of this report is to carry out a systematic review, with the objective of estimating the

clinical efficacy, safety, ethical issues and cost-effectiveness of the use of allograft for maxillary

sinus lift procedure with bone augmentation performed by the lateral window technique.

Methods

A computerized systematic search for human studies was performed in all languages covering

the period from January 1996 up to February 2013.The medical literature databases searched

include Medline, Pub Med, Embase, Cochrane library, ADA evidence based dentistry and

International Health Technology Assessment (HTAi).A search for the safety and related ethical

issues was also performed.

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Health Outcome

The final health outcome being assessed is the percentage of new bone formation induced by use

of solely allograft in sinus lift procedure. The data is based on the histomorphometric

measurements made on the histological sections obtained from the biopsy specimens of patients

collected after the healing period of the sinus graft.

Results

We found a total of 12 studies which met our inclusion criteria. The included studies are all case

series with a minimum follow-up period of 6 months. No randomized controlled clinical trials

were found. The 12 studies included deal with the histomorphometric measurement of

percentage new bone formed by the use of allograft calculated from the histological sections

obtained from biopsy specimens. Of the 12 studies, 5 compared the clinical efficacy of allograft

with those of other bone grafting materials.

Cost Analysis

The aspect of cost was not explicitly treated in any of the studies. This report addresses and

restricts the cost analysis to the cost of only the graft material used in the sinus lift procedure. As

the percentage of new bone formed does not depend on the volume of graft used for the sinus

lift, we have considered the cost of the graft material per cc for calculation of cost-effectiveness.

The average unit cost (per cc) of allograft, xenografts and synthetic bone graft materials are

$265, $132.5 and $104.5 respectively. Cost-effectiveness among different types of allograft is

not included as part of this report.

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Conclusion

There is evidence that allograft is clinically efficacious in inducing new bone formation

when used as a bone augmentation material in the maxillary sinus lift procedure.

The weighted average of percentage new bone formed per group and the average unit

costs in US($)/cc of allograft, xenograft and synthetic bone substitute are 34.7%,

38.14%,34.34% and $265, $132.5 and $104.5 respectively.

Taking into account both these parameters and the limitations of this report, it would be

appropriate to comment that the use of xenografts and synthetic bone substitutes prove to

be more cost-effective than the use of allograft in sinus lift procedures.

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Clinical Efficacy and Cost of Allograft use in Maxillary Sinus Lift Procedure

Performed by the Lateral Window Technique

1. Background

Maxillary Sinus

The maxillary sinus is a bilateral para-nasal air filled space, which is situated lateral to the nasal

cavity, superior to the maxillary teeth, inferior to the orbital cavity and anterior to the infra-

temporal fossa. The average dimensions of the sinus are 33 mm high, 23 mm wide,

and 34 mm in an anterior-posterior length 15

.It is pyramidal in shape and has an average volume

of 12.5 to 15cc. The sinus cavity is lined with a thin bi-laminar muco-periosteal membrane

known as the Schneiderian membrane (sinus membrane).The sinus opens into the semilunar

hiatus in the middle meatus of the lateral wall of the nose18

.

Maxillary Sinus Lift Procedure

With the increasing popularity of dental endosseous implants as the treatment choice for

replacement of missing teeth, rehabilitation of the edentulous posterior maxilla has become a

common clinical challenge owing to the insufficient bone volume resulting from pneumatization

of the maxillary sinus along with the resorption or loss of alveolar crestal bone2,20

. The initial

stabilization and long term success of implants have been difficult to achieve in this anatomical

site1,5

. Therefore, procedures such as the maxillary sinus elevation (lift) with bone augmentation

are essential to increase the amount of vertical bone height in the posterior maxilla for placement

of implants. The technique of sinus elevation was developed and introduced into dentistry by

Tatum5 in 1986 and published shortly thereafter by Boyne and James in 1980.However, this

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technique has been modified repeatedly and has evolved as a well documented viable treatment

option for patients with severely resorbed posterior maxillae6.

The primary indication of a sinus lift procedure is for planned re-construction of single, multiple

or completely edentulous posterior maxilla18

. As with any therapeutic procedure, the treatment

success depends on appropriate patient selection, adequate pre-surgical evaluation of the

anatomy coupled with sound surgical procedure and adequate post-surgical management.

Although, there are no absolute contra-indications to the sinus lift procedure, there are relative

contraindications based on certain local and systemic factors. Local factors include presence of

tumors, acute/chronic sinusitis, dental infection, severe allergic rhinitis, chronic use of topical

steroids and systemic factors include radiation therapy, uncontrolled metabolic diseases,

excessive tobacco use etc20

.

Sinus augmentation procedures can be successfully used for implant supported restorations in the

posterior atrophic maxilla when the residual bone is ≤ 5 mm5. This can be accomplished by using

1 or 2 stage approach and the criteria for selecting a 1-stage or 2-stage procedure are based

largely in the anatomic situation and the residual alveolar bone height. Generally, 5 mm of

alveolar bone height is used as borderline for determining when either a 1 or 2 stage procedure

should be used1, 20

. If the residual alveolar bone height is greater than 5 mm, a sinus lift

procedure with simultaneous implant placement are usually performed simultaneously, this is

defined as a 1-stage approach. The 2-stage approach involves a sinus lift procedure, following

the healing period for maturation of the bone graft and then the implant placement is completed.

The 2-stage approach is usually indicated in cases where the residual alveolar bone height is less

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than 5mm1. However, it is essential to note that, the most important factor in determining

whether implant(s) can be placed at the time of the sinus lift procedure is the ability to achieve

initial implant stability in the existing native bone rather than any measure of bone height20

.

The main goal of the sinus lift procedure with bone augmentation is to lift the sinus membrane

from the floor of the sinus, raise it up into the sinus cavity and to fill the newly created space

(between the sinus membrane superiorly and the deficient alveolar ridge inferiorly) with bone

grafting material. The techniques used for sinus lift procedure are differentiated based on the

anatomic location of the osteotomy used to gain access into the maxillary sinus. The most

common procedures used, at present, are the lateral wall antrostomy (lateral window technique)

and the crestal osteotomy technique. The crestal osteotomy technique is considered to be

“technique –sensitive”, “conservative” and “blind” approach to sinus elevation as it does not

allow the operator to visualize the sinus membrane15,20

.

This report deals with sinus lifts

performed only using the lateral window technique.

The lateral window technique is considered to be the most effective and efficient technique to

access the maxillary sinus and perform the sinus lift procedure. In this procedure, a

mucoperiosteal buccal flap is elevated exposing the lateral bony wall of the sinus antrum at the

edentulous region distal to the first premolar where an opening is created. The osteotomy can be

prepared with a high-speed round diamond or a piezo-electric bone surgery device. The

procedure could be completed in 2 ways – first, wherein the lateral bony window (trap

door/hinged window) created is hinged inwards as the superior wall of the newly created space

created for bone grafting (Figure 1 A to C) and second wherein the bony window(access

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window) is reduced to paper-thin layer, which can be easily harvested(access hole) and

incorporated into the bone graft (Figure 1 D to F).Elevation of the sinus membrane is

accomplished with hand instruments with great care to avoid perforation of the membrane. Once

elevated, the newly created space can be grafted with autogenous bone or bone substitutes or a

combination of both. The surgical procedure for implant placement is completed if 1-stage

approach is planned. Finally, the antrostomy and bone graft are covered with a barrier membrane

(usually resorbable membrane) and the flap is sutured.

The most common complication of the maxillary sinus lift procedure with bone augmentation is

the perforation of the sinus membrane which greatly depends on the anatomy of the sinus and the

skill and expertise of the operator15,18, 20

.

Figure 1: Illustration showing 2 techniques for the lateral window procedure to access the maxillary sinus for

bone augmentation. A to C illustrates the first technique - Trap Door/ Hinged Window technique; D to E

illustrates the second technique – Access Window (From Fig.73-6,Pg 690, Newman, M. G., Takei, H.,

Klokkevold, P. R., & Carranza, F. A. (2011).Carranza's Clinical Periodontology., 11th

Edition, Saunders.

Reproduced with permission)

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Bone Graft Materials

Sinus lift procedures aim at increasing the bone volume by augmenting the sinus cavity with

autologous bone and/ or commercially available bone graft bio-materials. Various grafting

materials have been successfully used, however, the question as to which material is the most

appropriate for sinus lifts is still a matter of debate4.

The four desired properties of bone graft materials are osteogenesis, osteoinduction,

osteoconduction, and osteointegration. The only graft material that contains all four qualities is

autologous bone17

. Osteogenesis is new bone formation that occurs from osteo-progenitor cells

that are present in the graft, survive the transplant, and proliferate and differentiate to osteoblasts.

The process of osteoinduction entails the stimulation and recruitment of nearby undifferentiated

mesenchymal stem cells to the graft site, where the cells are triggered to differentiate into

chondrocytes and osteoblasts. Osteoconduction is the in-growth of vascular tissue and

mesenchymal stem cells into the scaffold structure presented by the graft material.

Osteointegration is described as bonding of the host and the graft material and is vital to graft

survival.

The grafting materials used for sinus augmentation include autogenous bone(autograft),allograft

such as mineralized(FDBA) and de-mineralized freeze-dried bone allograft (DFDBA),

mineralized solvent-dehydrated bone allograft(MSDBA),de-mineralized bone matrix(DBM),

xenografts such as de-proteinized bovine bone granules(Bio-Oss) and synthetic bone substitutes

such as calcium carbonate, polylactide -polyglycolide polymers, calcium sulfate, hydroxyapatite

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etc. A combination of these materials has also been used5,6

. The various bone grafting materials,

with their characteristics, sources, advantages and disadvantages have been discussed in Table 1.

Although, theoretically, the risk of disease transmission exists with allografts and xenografts, it is

essential to note that the modern tissue processing techniques, adherence to good manufacturing

practices, rigid screening of potential tissue donors and sterility-validation studies minimize the

risk of disease transmission from banked tissues3.

Types of Allograft

Although autografts are the gold standard, allografts are much more accepted by patients as the

bone grafting material of choice. The grafts are prepared as fresh, frozen, freeze-dried,

mineralized, and de-mineralized, and are specially supplied by licensed tissue banks as cortical

chips, cancellous powder, cortico-cancellous blend, cortico-cancellous blocks etc. The properties

of the allograft are directly related to the steps taken in processing the material. The different

types of allograft have been discussed briefly in the following paragraphs.

Allografts for maxillofacial and periodontal use are generally de-mineralized freeze-dried bone

allografts (DFDBA) or mineralized freeze-dried bone allografts (FDBA) which are available in

different forms16

. DFDBA have been clinically used almost for over 40 years3,5

. Freeze-dried

bone allograft (FDBA) and de-mineralized freeze dried bone allograft(DFDBA) are both

harvested from cadaverous sources in the same manner, with the difference being that DFDBA

material undergoes the additional step of de-calcification. Exposure of bone morphogenetic

protein(BMP) by de-mineralization of the allograft is thought to enhance the osteogenic potential

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of the graft as they have the capacity to induce a phenotypic change of host pluripotent cells into

osteoblasts and cause bone formation2,3

.

Mineralized solvent-dehydrated bone allograft (MSDBA) is composed of a unique bone

substitute which differs from other forms of bone allograft processed via the standard

cryopreservation with respect to the processes used for tissue preservation and viral inactivation.

There are 5 timed steps involved in it, namely categorized as the proprietary Tutoplast process –

de-lipidization, osmotic contrast treatment, oxidation treatment with hydrogen peroxide, solvent

de-hydration and limited dose of gamma irradiation3,4

. MSDBA facilitates bone in-growth as the

mineral and collagen structures are maintained intact during the solvent preservation process4.

De-mineralized bone matrix (DBM) is a derivative of allograft bone. The advantage to using

DBM is its ability to be molded to fill the desired area with graft material17

. It is prepared by

pulverization of allogenic bone to a consistent size, followed by mild acid extraction of the

mineralized phase of bone14

. Manufacturers of de-mineralized bone matrices add different

carriers to the composite. It is generally available in a reverse-phase medium in paste or putty

consistency. De-mineralized bone matrix is osteoconductive but does not provide structural

support. Osteoinductive capabilities are increased because of the released growth factors during

the demineralization process8,13,14

. For these osteoinductive materials to act persistently, a carrier

(e.g. polaxamer) is used in DBM, so that BMPs can be released slowly and continuously7,8

. In

addition, the cancellous chips offer an osteoconductive scaffold for bone deposition and

remodeling7.

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2. Objective

The purpose of this report is to carry out a systematic review, with the objective of estimating the

clinical efficacy, safety, ethical issues and cost-effectiveness of the use of allograft for maxillary

sinus lift procedure with bone augmentation performed by the lateral window technique.

3. Health Outcome

The main health outcome being assessed is the percentage of new bone formation induced by use

of solely allograft in sinus lift procedure. The data is based on the histomorphometric

measurements made on the histological sections obtained from the biopsy specimens of patients

collected after the healing period of the sinus graft. The histomorphometric measurements made

and the percentage of each tissue type in the section ( i.e. newly formed bone, residual graft

material, bone marrow and connective tissue) measured are approximately the cross-sectional

area of each tissue type divided by the cross sectional area of the section1. Identification of the

new bone formation and differentiation from the residual graft particles had been accomplished

by evaluating the different maturity levels between newly formed bone and graft particles by

using differential staining properties, evaluating the different polarization patterns, as well as

evaluating the presence or absence of osteocytes in the lacunae. Graft particles were identified by

their typical appearance, especially the presence of empty lacunae6.

4. Methods

Search Strategy

A computerized systematic search for human studies was performed in all languages covering

the period from January 1996 up to February 2013.The medical literature databases searched

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include Medline, PubMed, Embase, Cochrane library, ADA evidence based dentistry and

International Health Technology Assessment (HTAi). A combination of MeSH subheadings and

keywords were used for the search. The search terms used were ([Sinus Floor Augmnetation] OR

[Maxillary Sinus] OR [sinus lift] OR [sinus floor] OR [sinus augment*]) AND ([Bone Matrix]

OR [deminerali?ed bone matrix] OR [minerali?ed bone matrix] OR [cancellous bone chip*] OR

[DBM] OR [bone allograft]) were used. A search for safety and related ethical issues were also

performed. Manual search of journals was not performed. The search was performed by one

reviewer(V.K.)

Inclusion Criteria

Human studies, in English language, assessing the final outcome (i.e. percentage of new bone

formed) of maxillary sinus lift procedure with use of solely allograft (100% only allograft) were

included. The review exclusively focused on studies applying the lateral window technique for

sinus lift and having a minimum follow-up period of 6 months. Studies comparing allograft with

other bone substitutes were included, if the outcome measure could be identified for allograft.

Exclusion Criteria

Articles reporting allograft mixed with other bone substitutes or platelet-rich plasma were

excluded. Publications with unavailability of full text were excluded. In addition, studies

addressing additional augmentation procedures at the same site and studies with insufficient or

missing data about quantitative measurement of new bone formed were excluded.

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Selection of Studies

The titles derived from this broad search were initially screened. Following this, the abstracts of

all selected titles were assessed and screened for meeting the inclusion criteria. If the title and

abstract did not provide sufficient information regarding the inclusion criteria, the full text was

obtained as well. Finally, the selection based on inclusion and exclusion criteria was made for

full –text articles by one reviewer (V.K.). For this purpose, Material and Methods and Results of

these studies were screened.

Quality Assessment

The quality assessment of the included studies was undertaken by two reviewers (V.K. and M.

J.) independently using the Methodological Index for Non-randomized Studies (MINORS)

checklist19

. Disagreements were resolved by discussion.

Data Extraction

Data were extracted by one reviewer (V.K.) and all the relevant characteristics of the study were

recorded. From the selected papers, data were extracted on author(s), year of publication, study

design, total number of patients, total number of sinuses grafted, follow-up period, baseline

height of the residual alveolar crest (mm), type of graft used and percentage of new bone formed.

5. Results

Study Characteristics

By electronic literature search, a total of 404 titles were identified, of which, 241 titles were

duplicates and were eliminated.163 abstracts were reviewed , full text analysis with quality

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assessment included 29 articles. Finally, 12 studies have been included in this report. The search

result is outlined in Figure 2. The included studies are all prospective case series except a study

by Cammack et al (2005) which is a retrospective case series. No randomized controlled clinical

studies and articles about safety and ethical issues were found.

Exclusion of Studies

The reasons for excluding studies after the full text was obtained were : Follow –up time less

than 6 months (5 articles), not measuring the final outcome quantitatively as % of new bone

COMPUTERIZED LITERATURE SEARCH: 404 Titles

DUPLICATE ARTICLES: 241

ABSTRACTS REVIEWED: 163

FULL TEXT OBTAINED: 29

TOTAL ARTICLES INCLUDED: 12

QU

AL

ITY

CH

EC

K

AS

SE

SS

ME

NT

Figure 2: Search Strategy Used for Identification of Studies

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formed (5 articles), use of mixture of grafts (4 articles), focus on other outcomes(2 articles) and

use of surgical technique than lateral window (1 article).

Included Studies

Twelve articles were selected for inclusion in this report and they deal with the

histomorphometric measurement of percentage new bone formed by the use of allograft. The

basic patient data of these 12 studies is summarized in Table 2. Ten studies reported inclusion-

exclusion criteria for their patients with mention of the administration of antibiotics as part of pre

and post surgical management protocol. Most often, patients with a history of sinusitis, immune

system disorders and uncontrolled systemic diseases were excluded. The details of the surgical

approach, simultaneous/staged implant placement, use of barrier membrane to cover the lateral

window, sinus membrane perforations, time and number of biopsies have been illustrated in

Table 3.

In the 12 studies, variety of allograft have been used and the following parameters were

quantitatively assessed (1) percentage of newly formed bone (2) percentage of residual graft (3)

percentage of soft tissue and connective tissue formed,, using histomorphometric methods. The

details of these 12 studies exhibiting the clinical efficacy of allograft in sinus lift procedure are

illustrated in Table 4. Of the 12 articles, 5 studies compared the new bone forming ability of

allograft with that autografts, xenografts and synthetic bone substitutes and have been

summarized in Table 5. The included studies revealed considerable variation in design i.e. the

baseline height of the residual alveolar ridge, type of allograft used, number of sinuses grafted,

number of biopsies, length of observation period. Among the included studies, a study by

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Scarano et al (2006) had the largest sample size of 144 sinus grafts and it compared the use of 9

different graft materials in sinus lift procedure, thereby, contributing majority of the data for

comparison of bone graft groups as against the other 4 comparative studies which had smaller

sample sizes and comparison groups. The results were expressed in Mean ± S.D. format only in

the study by Scarano et al.(2006). Therefore, meta-analysis was not applicable. However, as it

would be unethical to draw conclusions based on the results of one study (Scarano et al 2006),

we decided to use the data from the other 4 comparative studies as well, therefore, we have used

weighted average to compare the results. For purpose of calculation of results, in those studies

where number of biopsies were not mentioned, we have made an assumption that 1 biopsy was

obtained from each grafted sinus and hence, number of biopsies obtained is equal to the number

of sinuses grafted. The results of the weighted average from the 5 comparative studies of

allograft as opposed to other type of bone graft materials are presented in Table 6.

Within the limits of the study, histomorphometric measurements have demonstrated that

autografts (40.1% ) have the greatest potential for new bone formation, followed by xenografts

(38.14%), allografts (34.7% ) and synthetic bone substitutes(34.34%).Similarly, the results of the

weighted average of different types of allograft obtained from the 12 studies have been presented

in Table 7. Within the limits of the study, MSDBA(36.82%) has been shown to have greater

potential for new bone formation as compared to DFBDA(33.48%), FDBA(32.08%),

DBM(29.18) and CCBB(26.1%). Irrespective of the differences in weighted average of the

percentage new bone formed, it is essential to note that new bone formation was observed in all

the specimens that were taken from augmented sinus areas regardless of grafting materials.

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6. Cost Analysis

The aspect of cost was not explicitly treated in any of the studies. It is quite evident that there are

number of direct and in-direct costs involved in sinus lift procedure with bone augmentation.

However, this report addresses and restricts the cost analysis to the cost of only the graft material

used in the sinus lift procedure. The range and the average costs of the commercially available

bone graft materials have been calculated by taking into account the current market prices of a

minimum of 2 products per type of graft material and have been detailed in Table 8. For the

purpose of cost analysis, we have assumed that 1 CAN ($) =1US ($) and DBM has been

included in the group of allograft, although it is a derivative of allograft.

As the percentage of new bone formed does not depend on the volume of graft used for the sinus

lift, we have considered the cost of the graft material per cc for calculation of cost-effectiveness.

The average unit cost (per cc) of allograft, xenografts and synthetic bone graft materials are

$265, $132.5 and $104.5 respectively. Autografts has been excluded from the cost-analysis

owing to it being the gold-standard graft and it has its own advantages and disadvantages as

discussed earlier. Cost-effectiveness among different types of allograft is not included as part of

this report.

7. Conclusion

There is evidence that allograft is clinically efficacious in inducing new bone formation when

used as a bone augmentation material in the maxillary sinus lift procedure. The weighted average

of percentage new bone formed per group and the average unit costs in US($)/cc of allograft,

xenograft and synthetic bone substitute are 34.7%, 38.14%,34.34% and $265, $132.5 and $104.5

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respectively. Taking into account both these parameters and the limitations of this report, it

would be appropriate to comment that the use of xenografts and synthetic bone substitutes prove

to be more cost-effective than the use of allograft in sinus lift procedures.

This report has a number of limitations as the included studies are all case series. Also, the

percentage of new bone formed could vary as per the biopsy sites and also the software used for

histomorphometric analysis. It is, therefore essential to have larger studies such as randomized

controlled clinical trials to lead to more definitive conclusions to provide evidence-based

information to the clinicians regarding the selection of a cost-effective graft material for sinus

lifts.

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Table 1: Types of Bone Graft Materials

TYPE OF

GRAFT

CHARACTER--

ISTICS ADVANTAGES

DISADVAN-

TAGES

SOURCES/

EXAMPLES

AUTO-

GRAFT

Grafts transferred

from one site to

another site within

the same individual16

.

Gold standard graft

-Osteogenic,

osteoinductive

and osteoconductive

properties

-No fear of disease

transmission and

antigenicity

-Need for second

surgery

-Donor site

morbidity

-May be available

in limited

quantities4

Extraoral

sources :iliac

crest, anterior

tibia

Intraoral

sources:

mandibular

symphysis,

maxillary

tuberosity etc

ALLO-

GRAFT

A graft that taken

from a

member of the same

species as the

recipient but is

genetically

dissimilar17

- Easily available

without second

surgery

-Osteoconductive and

osteo-inductive*

properties

- Closely matches the

recipient in

constitutional

elements and

Architecture16

-Could trigger

immune reactions3

Cadaver cortical/

cancellous bone,

Freeze Dried

Bone Allograft

(FDBA) , De-

mineralized

Freeze-Dried

Bone Allograft

(DFDBA),De-

mineralized

Bone

Matrix(DBM)

XENO-

GRAFT

A graft derived from

genetically different

species

than the recipient17

- Common alternative

to autogenous bone

- Osteoconductive

properties8

-Slow turnover rate

of cortical bone16

-Could trigger

immune

reactions3,16

De-proteinized

Bovine Bone

granules (Bio-

Oss)

SYNTHE-

-TIC

BONE

Fabricated graft

materials

-Osteoconductive

properties

-Available in

unlimited volume

-No potential to

transmit -disease

-Could trigger

immune reactions16

Calcium sulfate,

bioactive

glasses,

Hydroxyapaptite,

Beta-tricalcium

phosphate etc.

(*)indicates DBM8,13

and DFDBA15

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NO. OF AGE BASELINE NO. OF

PATIENTS (years) BONE ht. UNILATERAL BILATERAL TOTAL NO.OF IMPLANTS

(N) (mm) (only) SINUSES GRAFTED(n) PLACED

2001 Karabuda et al. 8 29-65 6.3 (1-8) 7 1 9 19

2005 Cammack et al. 44 21-76 ≤5 38 3 44 NS

2005 Noumbissi et al. 7 56-81 ≤5 4 3 10 NS

2006 Gapski et al. 4 42-62 NS 4 0 4 7

2006 Scarano et al. 94 52-68 3­5 44 50 144 362

2008 Kolerman et al. 19 43-78 ≤6 15 4 23 NS

2009 Kim et al. 8 31-62 <6 6 2 10 16

2009 Sohn et al. 5 41-67 3.2(1-6) 5 0 5 13

2010 Avila et al. 20 23-69 NS 17 3 23 39

2010 Chaushu et al. 31 25-65 ≤4 31 0 31 76

2011 Annibali et al. 7 31-70 ≤4 3 4 11 25

2012 Kolerman et al. 5 54-65 <5 0 5 10 NS

NO. OF SINUS LIFTS

YEAR AUTHOR

SIMULTANEOUS SURGICAL MEMBRANE NO. OF SINUSES TIME OF NO. OF

IMPLANT PLACEMENT/ APPROACH COVERAGE OF WITH MEMBRANE BIOPSY BIOPSIES

STAGED APPROACH FOR SINUS LIFT LATERAL WINDOW PERFORATION (months)

2001 Karabuda et al. Simultaneous/Staged Trap Door NO 2 6 NS

2005 Cammack et al. NS NS Resorbable NS 6 to 36 NS

2005 Noumbissi et al. Staged Trap Door NO NS 10 NS

2006 Gapski et al. Staged Access Hole NO NS 6 to 7.2 NS

2006 Scarano et al. Simultaneous Trap Door NO 0 6 144

2008 Kolerman et al. Staged Access Hole Resorbable NS 9 23

2009 Kim et al. NS Access Hole Resorbable NS 6.2 8

2009 Sohn et al. Simultaneous Access Hole NO 2 6 5

2010 Avila et al. NS NS Resorbable 5 6 NS

2010 Chaushu et al. Simultaneous NS Resorbable 6 9 31

2011 Annibali et al. Staged Trap Door Resorbable 0 8.1 11

2012 Kolerman et al. Staged NS Resorbable 0 9 10

YEAR AUTHOR

Table 2: Basic Patient Data

All the studies mentioned in the above table are case series. NS: Not Specified

Table 3: Characteristics of Surgical Procedures

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TYPE OF NO. OF SINUSES BASELINE % OF NEW % SOFT TISSUE FORMED % RESIDUAL

ALLOGRAFT GRAFTED BONE ht. BONE (MARROW & GRAFT

(n) (mm) FORMED CONNECTIVE TISSUE)

2001 Karabuda et al. DFDBA 1 6.3 (1-8) 70-75 15 5 to 10

FDBA 31 41.07 ± 19.17 51.18 ± 22.71 9.56 ± 17.86

DFDBA 13 36 ± 19.12 53.89 ± 16.97 10.11 ± 12.80

2005 Noumbissi et al. MSDBA 6 ≤5 40.33 NS 4.67

2006 Gapski et al. MSDBA 1 NS 68.9 NS NS

2006 Scarano et al. DFDBA 16 3 to 5 29 ± 2.3 37 ± 1.6 34 ± 1.2

2008 Kolerman et al. FDBA 23 ≤6 29.1 ± 9.78 51.91 ± 7.49 19 ± 9.34

2009 Kim et al. DBM +CC 10 <6 23.8 ± 4.2 67.2 ± 9.4 9.1 ± 8.1

2009 Sohn et al. DBM + CC 5 3.2(1-6) 37.8 ± 20.9 31.1 ± 9.6 NS

2010 Avila et al. FDBA 23 NS 23.02 ± 19.11 54.73 ± 13.51 22.25 ± 20.3

2010 Chaushu et al. CCBB 31 ≤4 26.1 ± 15 49.2 ± 20.4 24.7 ± 19.4

2011 Annibali et al. MSDBA 11 ≤4 32 ± 1.6 34 ± 1.6 31 ± 1.4

2012 Kolerman et al. FDBA 5 <5 31.8 46.7 21.5

2005 Cammack et al. ≤5

YEAR AUTHOR

TOTAL NO. OF BASELINE TIME OF % OF NEW

SINUSES BONE ht. BIOPSY TYPE OF GRAFT MATERIAL NO.OF SINUSES BONE FORMED

GRAFTED (mm) (months) GRAFT (GROUPS) GRAFTED PER GROUP

ALLO DFBP (DFDBA) 1 70-75

XENO DBBG 5 50

SYN PHA 3 20-35

ALLO MSDBA 6 40.33

ALLO+XENO * DFDBA+DBBG(1:1) 4 38.75

ALLO MSDBA 1 68.9

ALLO+AUTO * MSDBA + autogenous bone 3 74.8

ALLO DFDBA 16 29 ± 2.3

AUTO Autologous bone 16 40.1 ± 3.2

Calcium Carbonate 16 39 ± 3.1

Bioactive Glass 16 31 ± 1.9

Polymer of Polylactic & Polyglycolide Acids 16 33 ± 2.2

Calcium Sulfate 16 38 ± 3.2

Hydroxyapatite 16 32 ± 2.5

Bovine deproteinized bone 16 39 ± 1.6

Bovine derived bone and peptide 16 37 ± 2.3

ALLO FDBA 5 31.8

XENO DBBM 5 27.2

COMPARISON GROUPS

≤5

6.3 (1-8) 6

10

NS 6 to 7.2

SYN

XENO

2006 Scarano et al. 144 3 to 5 6

YEAR AUTHOR

2006 Gapski et al. 4

2001 Karabuda et al. 9

2005 Noumbissi et al. 10

2012 Kolerman et al. 10 <5 9

Table 4: Summary of clinical efficacy of allografts

DFDBA: De-Mineralized Freeze Dried Bone Allograft, FDBA: Freeze-Dried Bone Allograft, MSDBA :

Mineralized Solvent Dehydrated Bone Allograft, RPMBA : Radiation Preserved Bone Allograft, DBM: De-

Mineralized Bone Matrix, CC- Cancellous Chips, CCBB: Cotico-Cancellous Bone Block, NS : Not Specified

Table 5: Comparative Studies

(*) indicates that the data has not been included in calculation of weighted average

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TYPE OF NO.OF SINUS Avg. % OF NEW TOTAL NO.OF WEIGHTED AVG. OF %

GRAFT BIOPIES BONE FORMED BIOPSIES NEW BONE FORMED

(GROUPS) PER GROUP PER GROUP

Autograft 2006 Scarano et al. 16 40.1 16 40.1

2001 Karabuda et al. 1 72.5

2005 Noumbissi et al. 6 40.33

2006 Gapski et al. 1 68.9

2006 Scarano et al. 16 29

2012 Kolerman et al. 5 31.8

2001 Karabuda et al. 5 50

16 39

16 37

2012 Kolerman et al. 5 27.2

2001 Karabuda et al. 3 27.5

16 39

16 31

16 33

16 38

16 32

29

42

83

34.7

38.14

34.34

YEAR AUTHOR

Allograft

Xenograft

Synthetic

2006 Scarano et al.

2006 Scarano et al.

TYPE OF NO.OF SINUS Avg. % OF NEW TOTAL NO.OF WEIGHTED AVG. OF %

ALLOGRAFT BIOPSIES BONE FORMED BIOPSIES NEW BONE FORMED

(GROUPS) PER GROUP PER GROUP

2001 Karabuda et al. 1 72.5

2005 Cammack et al. 13 36

2006 Scarano et al. 16 29

2005 Cammack et al. 31 41.07

2008 Kolerman et al. 23 29.1

2010 Avila et al. 23 23.02

2012 Kolerman et al. 5 31.8

2009 Kim et al. 8 23.8

2009 Sohn et al. 5 37.8

2005 Noumbissi et al. 6 40.33

2006 Gapski et al. 1 68.9

2011 Annibali et al. 11 32

CCBB 2010 Chaushu et al. 31 26.1 31 26.1

36.82

YEAR AUTHOR

DFDBA

FDBA

DBM + CC

30

82

13

33.48

32.08

29.18

MSDBA 18

Table 6: Weighted average of new bone formed using different graft materials

Data used in this table is from the 5 comparative studies detailed in Table 5.

Table 7: Weighted average of new bone formed using different types of allografts

Table

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TYPE OF PRICE RANGE AVG. PRICE

BONE GRAFT US ($) / per cc US ($)

ALLOGRAFT 80 to 450 265

XENOGRAFT 125 to 140 132.5

SYNTHETIC 84 to 125* 104.5

8: Cost Summary

cc : cubic centimeter, (*) indicates price in CAN($)

Assumption : 1 CAN($) = 1 US($)

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