SYMPOSIUM ON BMP-2:

STATE OF THE ART

THE SINUS GRAFT

JAY P. MALMQUIST DMD

THE MAXILLARY SINUS

GRAFT

SINUS GRAFTING INCIDENCE

SINUS GRAFTS 2009
SINUS GRAFTS 2010
SINUS GRAFTS 2011

82,000
97,000
114,300

THIS REPRESENTS AN 18 % GROWTH

TOTAL DENTAL MEMBRANE
PROCEDURES BY 2011

904,000

SINUS GRAFTING TODAY: WHAT DO

WE KNOW
Implant placement can occur at the time of
grafting or as a delayed procedure
Delayed time frame is often 6-9 months prior
to placement
Implant success is well documented and is
used as the main criteria for graft success

THE
TECHNIQUE

LATERAL WALL OSTEOTOMY

SINUS MEMBRANE EXPOSED

ELEVATION OF MEMBRANE

THE
TECHNIQUE

GRAFT PLACEMENT
ELEVATION OF THE MEMBRANE

GRAFT MATERIAL

?
MEMBRANE PLACEMENT

SINUS GRAFTING TODAY:

THE GRAFTING MATERIALS
GRAFTING MATERIALS:
FIVE MAJOR GROUPS

AUTOGENOUS
ALLOGRAFTS (CADAVER BANK BONE)
ALLOPLASTS (SYNTHETIC MATERIALS)
XENOGRAFTS (NON-HUMAN SPECIES)
BMP-2 AND RELATED CELL PROTEINS/
GROWTH FACTORS

GRAFTING MATERIALS CAN BE USED

ALONE OR IN SOME COMBINATION

BMP-2 NEWEST GRAFT

MATERIAL FOR THE MAXILLARY
SINUS

Proliferation and Morphogenesis

Proliferation

Morphogenesis

Stem
Cell

Osteobla
st

PDGF
Mitogen
non-specific recruitment and proliferation of cells

Proliferation

One stem cell divides into two stem cells

Differentiation

Stem
Cell

Osteoblas
t

Levels of Scientific Evidence - Guidelines for assessing quality of

published clinical data
Level 1
Evidence with a high
degree of reliability

Studies that use well-tested methods to make comparisons in a fair way and where the results leave
very little room for uncertainty.
Examples:
Large, high-quality randomized controlled studies
Statistical significance difference
THIS WHERE WE WOULD LIKE TO OPERATE

Level 2
Evidence with reliability
but open to debate

Studies that use well-tested methods to make comparisons in a fair way but where the results leave
room for uncertainty.
Examples:
Small randomized controlled trials
Randomized controlled trials with large numbers lost to follow-up

Level 3
Some evidence without a
high degree of
reliability

Studies where the results are doubtful because the study design does not guarantee that fair
comparisons can be made.
Examples:
Case Series with retrospective control
Individual case series with control

Level 4
Some evidence but based
on studies without
comparable groups

Studies where there is a high probability that results are due to chance.
Examples:
Cases series with no control or only historical control

Bhandari, M Swiontkowski MF, Einhorn, TA, et al. JBJS, 2004

BMP-2 Bone Graft for Dental Bone Regeneration

3 Prospective, Multicenter, Randomized Controlled Clinical
Trials
LEVEL 1 EVIDENCE

The AAP Foundation

2005 Tarrson
Research Award in
Oral Plastic Surgery

The AAOMS Journal

Editorial Board 2005
Daniel M. Laskin
Award

Largest Dental Bone Graft Study

Supporting a FDA Approval as an
Autograft Alternative for Bone
Regeneration and Dental Implant
Placement

Maxillary Sinus Floor

Augmentation Procedure with
BMP-2

THE CLASSIC
APPROACH

Maxillary Sinus Augmentation Studies

Prospective, multicenter, randomized, controlled
human clinical trials
Phase II Study, 6 sites
60 patients
20 INFUSE Bone Graft patients
20 other rhBMP-2/ACS patients
20 autograft patients

Phase III Study, 21 sites

160 patients
80 INFUSE Bone Graft patients
80 autograft patients

220 Patients for Phase II and III Combined

To demonstrate that rhBMP-2/ACS

regenerates or grows normal physiologic bone

provides bone for dental restorations or placement of dental implants
produces stable bone under functional loading

To demonstrate safety in oral/maxillofacial

indications
Boyne
et al, JOMS,
2005 Triplett et al,

SINUS STUDY RESULTS WITH

BMP-2

Sinus Augmentation Bone Growth

Treated with INFUSE Bone Graft
All patients had 6 mm or less of native bone in the posterior maxilla
98 out of 99 patients formed bone in their sinus post-INFUSE Bone
Graft placement
On average, 8.2 mm of new bone (height) was formed for an average
of 13.8 mm in each sinus, available for dental implant placement

Pre-Op
(3.9 mm Baseline)
INFUSE Bone
Graft All 99
Patients

Boyne et al, JOMS,

2005 Triplett et al,

6 Months Post-Op
(16.0 mm)
CT Scan of de novo Bone
Induced by INFUSE Bone Graft

Sinus Augmentation Bone Growth by

Evaluable Site Treated with INFUSE Bone
PreGraft
Patients were required to
op

have at least 1 site with less

than 6 mm of native bone to
be included in the study

16-weeks Post INFUSE Bone Graft

Placement

Patients received multiple

implants, some in sites with
greater than 6 mm of bone due
to anatomical configuration

Boyne et al, JOMS,

2005 Triplett et al,

Sinus Augmentation Studies

Bone Quality Supports Dental Implant
Bone
Graft

Boyne et al, JOMS,

2005 Triplett et al,
JOMS, 2009

Similar
Trabecular
Volume and
Thickness
Both with 90-95%
lamellar bone with
small amounts of
immature bone
INFUSE Bone
Graft induced viable
bone

BMP-2 Bone
Graft

Sinus Augmentation De Novo Bone Formation

AUTOGRAFT

rhBMP-2/ACS

Labeling
Yellow - 10 days post-op (tetracycline hydrochloride)
Orange - 3 months post-op (democlocycline)
rhBMP-2/ACS demonstrated substantial, rapid de novo bone
formation
Bone Graft group demonstrated variable de novo bone

Major Concern is Space

Maintenance
Being able to maintain space during
healing is a major issue
Sinus membrane will not be completely
supported by ACS and BMP-2
Cannot realize the full potential of the
BMP-2 do to lose of space
Being able to focus the bone growth is
very important.

SPACE MAINTENANCE
MONKEY STUDY DONE MORE THAN 10 YEARS AGO
REINFORCES THE ISSUES OF SPACE
MAINTENANCE; WE LOOKED AT 82 MONKEYS: 164
SITES

rhBMP-2/ACS in Sinus Inlay Graft

rhBMP-2/ACS graft shows very

little support for the over lying
tissue

Graft placed

BMP-2 SINUS GRAFTING CASE

SINUS GRAFT WITH BMP-2

BMP-2 GRAFT MATERIAL IN PLACE

INCREASED VERTICAL HEIGHT GOAL OF THERAPY

THE HEIGHT IS A FUNCTION OF SPACE MAINTENANC

THE TREATMENT PLAN

PRE WAX

IMPLANTS PLACED: FLAPLESS

APPROACH

THE OSTELL MEASUREMENT

OF 81 ISQ IS EXCELLENT
STABILITY FOR THE DISTAL
IMPLANT IN rhBMP-2
GENERATED BONE

SEVERE SINUS ATROPHY

And Space Maintenance
THE QUESTION: CAN WE
IMPROVE THE PREDICTABLE
HEIGHT OF BONE USING BMP-2?

SINUS MEMBRANE ELEVATION

WITH ANTRAL BALLOON TECHNIQUE

SINUS MEMBRANE

COURTESY OF DAN SPAGNOLI DDS,PHD

SPACE MAINTENANCE

3-D COLLAGEN
CAPSULE

rhBMP-2 ON ACS

COLLAGEN 3-D CAPSULE ALLOWS FOR SPACE MAINTENANCE

COLLAGEN CAPSULE

COLLAGEN CAPSULE
A 3-D PRODUCT FOR GRAFTING THAT IS
RESORBABLE
ALLOWS FOR FOCUSED BONE GRAFTING
SPACE MAINTAINER FOR ALL GRAFTING
PRODUCTS, MANY OF WHICH DO NOT
ALWAYS PROVIDE GOOD SUPPORT
GRAFT CONTAINMENT DEVICE: MAINTAINS
THE MATERIAL AT THE DEFECT SITE
PROTECTS SINUS MEMBRANE; ADJUNCT IN
SINUS MEMBRANE PERFORATIONS

THE SCIENCE OF THE

COLLAGEN CAPSULE CROSS
LINKS

TOXIC CROSS LINKING

CROSS LINKING A KEY TO MEMBRANE LONGEVITY

Cranium (bone)

UBT Collagen

Collagen Implanted for 6 Weeks (Rat

Cranium Model)

ALL COLLAGEN
ELIMINATES
SECOND SITE
SURGERY

BONE GROWTH

FOUR MONTHS

BEFORE

FOUR MONTHS
NORMAL BONE
FORMATIONS AT
4 MONTHS

HISTOLOGY FROM GRAFT SITE

SINUS BONE HEIGHT AT LOADING

SINUS SURGERY
SINGLE LARGEST COMPLICATION:
MEMBRANE PERFORATION

MEMBRANE PERFORATION
81 SINUS GRAFTS
36 PERFORATIONS.44%
MEMBRANE PERFORATIONS WERE
STRONGLY ASSOCIATED WITH
POSTOPERATIVE COMPLICATIONS SUCH
AS INFECTION
IJOMI 2004
PROBABLY A MUCH HIGHER INCIDENCE
THAN REPORTED IN THE LITERATURE

GRAFT CONTAINMENT
SINUS

BMP-2+ MinerOss

GRAFT CONTAINMENT

NO CONTAINMENT OF GRAFT MATERIAL LEADS TO MASSIVE INFECTION

FOCUSED BONE GRAFTING

WHY?
POSITION BONE IN DESIRED PLACE
CAN BETTER QUANTIFY GRAFT
MATERIAL
QUANTITY IS A QUESTION OF COST
FOR PATIENT AND DOCTOR
BETTER OVERALL TREATMENT
PLANNING
CONTAINMENT IS ALWAYS IMPORTANT

RECONSTRUCTION
POSTERIOR MAXILLA

FOCUSED GRAFTING
WITH CONTAINMENT OF
BMP-2 AND ALLOGRAPH
REDUCES COSTS
BY PRECISE PLACEMENT OF
GRAFTING MATERIALS
IN SELECTED AREAS

FOCUSED BONE GRAFT

MAXILLARY SINUS BMP-2 WITH
CONTAINMENT

FOCUSED
BONE GRAFT

THE ISSUE IS BEING ABLE TO GROW BONE IN

A SELECTED AREA

FOCUSED GRAFT BMP-2 + FDMBA

(MINEROSS)

MINERALIZED BONE ALLOGRAFT

cancellous
cortical

THIS IS A GREAT
COMBINATION
Mineralized bone chips
Blend of cancellous and cortical
particles
Ideal particle range (750 1400
microns)

BMP-2
SPONGES

WILL HELP WITH SPACE MAINTANENCE: GOOD TISSUE SUPPORT

COST BECOMES LESS

OF A FACTOR!

DOSAGE: 2.8 CC/ 4.2 MG VIAL

STAGE TWO SURGERY

FOCUSED BONE GRAFT

MAXILLARY SINUS

FINISHED RESULT
ON RECALL

SECOND CASE:
FOCUSED BONE GRAFT

DOSAGE? X SMALL KIT

1.4CC/ 2 1.05MG VIALS
THE POWER OF GRAFT CONTAINMENT

FOCUSED BONE GRAFT

FINISHED CASE:
THE PATIENT ALSO
HAD A ANTERIOR
MAXILLARY BONE GRAFT

CASE III

CASE III

SMALL KIT 2.8cc 4.2mg.

FOCUSED BONE
GROWTH

POST OPERATIVE IMAGES

AT 10 WEEKS

20 MM

FOCUSED GRAFTING REDUCES COST

FOR PATIENT AND CREATES A MORE
EFFICENT PROCEDURE

3 MONTHS POST PLACEMENT

THE TAC!

BMP-2 + CAPSULE

NO ALLOGRAFT USED

SUMMARY
TAKE AWAY THOUGHTS BMP-2
KEYS TO SUCCESS IN SINUS GRAFTING
ADEQUATE BLOOD SUPPLY
CORRECT DOSAGE OF BMP-2
SPACE MAINTENANCE CHOICE OF
MATERIALS/METHODS
MAINTAINING THE INTEGRITY OF THE SINUS
MEMBRANE
MEMBRANE PROTECTION OF THE GRAFT MATERIAL
ADEQUATE HEALING TIME 4-6 MONTHS
GOOD SURGICAL TECHNIQUES
KNOW YOUR MATERIALS

THANK YOU