ESTHETIC DENTISTRY

Straumann® Biomaterials

Straumann® Emdogain®Orchestrating periodontal regeneration.

At a glance

Summary

Straumann® Emdogain®

Clinical evidence

How it works

What’s in it for you?

Technical information

Clinical cases

What leading experts say

At a glance

• Gel containing Enamel Matrix Derivative

• Promotes true periodontal regeneration¹ of the:

– Cementum – Periodontal ligament – Alveolar bone

• Indications: – Intrabony defects – Recession defects – Furcation defects

1 Miron RJ, Sculean A, Cochran DL, Froum S, Zucchelli G, Nemcovsky C, Donos N, Lyngstadaas SP, Deschner J, Dard M, Stavropoulos A, Zhang Y, Trombelli L, Kasaj A, Shirakata Y, Cortellini P, Tonetti M, Rasperini G, Jepsen S, Bosshardt DD. Twenty years of enamel matrix derivative: the past, the present and the future. J Clin Periodontol 2016; doi: 10.1111/jcpe.12546

At a glance

Straumann® Emdogain® in statistics:

1 McGuire MK, Scheyer ET, Nunn M. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue: com-parison of clinical parameters at 10 years. J Periodontol. 2012 Nov;83(11):1353-62 / 2 Sculean A, et al. Ten-year results following treatment of intrabony defects with enamel ma-trix proteins and guided tissue regeneration. J Clin Periodontol. 2008 Sep;35(9):817-24

* Based on the number of syringes sold to date, globally

** According to PUBMED search for “Emdogain” or “enamel matrix derivative”

*** Based on a global post-surgical complicationcomplication rate of less than 0.002 %

> 20 years on the market

> 2 million patients treated*

> >

600 clinical & 1,000 scientific publications**

Extremely well tolerated***

Stable results documented

over 10 years in 2 indications¹²

• Improved and predictable clinical results

• Patient satisfaction

• Less complications

What’s in it for you?

30

20

10

0

40

What’s in it for you?

Improved and predictable results in intrabony defects¹

Almost 2× as many defects achieve ≥ 4 mm CAL (Clinical Attachment Level) gain after 1 year

1 Tonetti MS, Lang NP, Cortellini P, Suvan JE, Adriaens P, Dubravec D, Fonzar A, Fourmousis I, Mayfield L, Rossi R, Silvestri M, Tiedemann C, Topoll H, Vangsted T, Wallkamm B.Enamel matrix proteins in the regenerative therapy of deep intrabony defects. J Clin Periodontol. 2002 Apr;29(4):317-25

Percentage of patients with highly significant outcome (CAL gain of > 4 mm) 1 year post-operative in the treatment of intrabony defects

% of patients

■ Open Flap Debridement (OFD)

■ Open Flap Debridement with Straumann® Emdogain®

75%

50 %

25%

0 %

100 %

CAFCAF with Emdogain®

75%

50 %

25%

0 %

100 %

CAFCAF with Emdogain®

75%

50 %

25%

0 %

100 %

CAFCAF with Emdogain®

75%

50 %

25%

0 %

100 %

CAFCAF with Emdogain®

What’s in it for you?

Improved and predictable results in recession defects¹

CAF (Coronally Advanced Flap) + Emdogain® achieves 40 % more root coverage than CAF alone.

Percentage of complete root coverage 18 months after surgery

1 Pilloni A, Paolantonio M, Camargo PM. Root coverage with a coronally positioned flap used in combination with enamel matrix derivative: 18-month clinical evaluation. J Periodontol. 2006 Dec;77(12):2031-9.

CAF with Emdogain® CAF

Thanks to:

• Tooth preservation

• Improved esthetics

• Less post-surgical pain and swelling

What’s in it for you?

Patient satisfaction

What’s in it for you?

Patient satisfaction thanks to less pain and swelling• Reduce post-surgical inflammation of oral surgical procedures

5⊗more patients without

pain after 1 week

7⊗more patients without swelling after 1 week

• In case of recession coverage, Straumann® Emdogain® obviates the need for an autologous connective tissue graft, a painful procedure

Less complications compared to surgeries involving membranes¹

What’s in it for you?

Less complications

1 Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Mer-li M, Cortellini P, Suvan JE. Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter practice-based clini cal trial.J Periodontol. 2004 May;75(5):726-33.

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How it works

Intrabony defect

Alveolar bone

Straumann® Emdogain® is applied and forms a matrix on the root surface.

Mesenchymal stem cells are attracted to the site and proliferate.

The cells secrete specific cyto-kines and autocrine substances.

Cells differentiate into cementoblasts.

The newly formed cementum increases in thickness and the periodontal fibers are anchored in it.

Within months, the periodontal ligament is formed.

Bone grows in the defect. The entire periodontium has been regenerated.

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Technical informationSINGLE PACKS

075.127W Straumann® Emdogain® 0.15 ml Singlepack

075.101W Straumann® Emdogain® 0.3 ml Singlepack

075.102W Straumann® Emdogain® 0.7 ml Singlepack

MULTIPACKS (3 × Straumann® Emdogain® + 3 × PrefGel®)

075.114W Straumann® Emdogain® 0.3 ml Multipack

075.116W Straumann® Emdogain® 0.7 ml Multipack

5-PACKS

075.098W Straumann® Emdogain® 0.15 ml 5-Pack

PREFGEL®

075.203W PrefGel® 0.6 ml, 5-Pack

Prof. Dr. Giovanni Zucchelli, University of Bologna, Italy

“Because Emdogain® improves soft tissue healing, it …”

Prof. Dr. Andrea Mombelli, University of Geneva, Switzerland

“The advantage of using a product which is 20 years old …”

Prof. Dr. Miron Weinreb, Tel Aviv University, Israel

“Emdogain® improves healing of oral mucosa incisional …”

Prof. Dr. David Cochran, University of Texas Health Science Center San Antonio, USA

“Straumann® Emdogain® stimulates …”

What leading experts say

The advantage of using a product which is 20 years old is that we know the product and we know that it is safe.

What leading experts say

Prof. Dr. Andrea Mombelli, University of Geneva, Switzerland

Straumann® Emdogain® stimulates the regeneration of both the hard and soft tissues of the periodontium at the same time. Every time I expose a tooth root surface in a patient, I apply Emdogain® to stimulate cementum formation. I have nothing to lose and a lot to gain.

What leading experts say

Prof. Dr. David Cochran, University of Texas Health Science Center San Antonio, USA

Because Emdogain® improves soft tissue healing, it helps me meet the high expectations of my patients in terms of esthetics.

What leading experts say

Prof. Dr. Giovanni Zucchelli, University of Bologna, Italy

Emdogain® improves healing of oral mucosa incisional wounds by promoting different biological events occurring during healing.

What leading experts say

Prof. Dr. Miron Weinreb, Tel Aviv University, Israel

• Long-term clinical evidence in intrabony defects

• Long-term clinical evidence in recession defects

• Clinical evidence in furcation defects

• Less complications compared to membranes

• Human histological evidence of true regeneration – recession defects

Clinical evidence

* S CAL gain between OFD and all other

after 1 year

after 10 years

0

CAL gain (mm)

2.01.8

3.2

2.8

3.3

2.9

3.4

2.9

EMD = Straumann® ®Emdogain

GTR = Guided Tissue Regeneration (membrane)

OFD = Open Flap Debridement alone

EMD

OFD

*

GTR

EMD

GTR

1.0

2.0

3.0

4.0

treatments approaches

tatistically significant difference in

* S CAL gain between OFD and all other

after 1 year

after 10 years

0

CAL gain (mm)

2.01.8

3.2

2.8

3.3

2.9

3.4

2.9

EMD = Straumann® ®Emdogain

GTR = Guided Tissue Regeneration (membrane)

OFD = Open Flap Debridement alone

EMD

OFD

*

GTR

EMD

GTR

1.0

2.0

3.0

4.0

treatments approaches

tatistically significant difference in

Clinical evidence

Long-term clinical evidence in intrabony defects¹

Study Design Randomized, controlled, prospective, single-center study

Population 38 patients, defects with probing depth of > or = 6 mm and intrabony component > 3 mm

Modalities Open flap debridement (OFD)

Emdogain®

Membrane

Emdogain® + membrane

Duration Regular maintenance program (4 times per year)

Results Significantly higher clinical attachment level (CAL) gain with Emdogain® compared with OFD

Clinical results can be maintained over 10 years

Adding a membrane to Emdogain® does not improve the result

1 Sculean A, et al. Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration. J Clin Periodontol. 2008 Sep;35(9):817-24

* S CAL gain between OFD and all other

after 1 year

after 10 years

0

CAL gain (mm)

2.01.8

3.2

2.8

3.3

2.9

3.4

2.9

EMD = Straumann® ®Emdogain

GTR = Guided Tissue Regeneration (membrane)

OFD = Open Flap Debridement alone

EMD

OFD

*

GTR

EMD

GTR

1.0

2.0

3.0

4.0

treatments approaches

tatistically significant difference in

CAL gain (mm)

* Statistically significant difference in CAL gain between OFD and all other

treatments approaches

after 1 year

after 10 years

5

mm

Baseline 1 year 10 years

4

3

2

1

0 * **

*

CTG + CAF

* Significant difference from baseline

Values in figures show mean actual levels at each time point

Emdogain® + CAFEmdogain®  +  CAF CTF  +  CAF

Clinical evidence

Long-term clinical evidence in recession defects¹

Study Design Randomized, controlled, split mouth, single-center study

Population 9 patients with Miller class I or II recession defects (Baseline recession ≥ 4 mm with ≤ 2.5 mm keratinized tissue)

Modalities Coronally Advanced Flap (CAF) + Emdogain®

CAF + Connective Tissue Graft (CTG)

Results Both treatments show stable, clinically effective outcomes

No significant difference between the two treatments at 10 years

Patients satisfaction with the treatment is higher for Emdogain®

Emdogain® is a viable alternative to CTG and can avoid complications associated with donor site surgery

1 McGuire MK, Scheyer ET, Nunn M. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue: comparison of clinical parameters at 10 years. J Periodontol. 2012 Nov;83(11):1353-62

* Significant difference from baseline

Recession depth

mm Values in figures show mean actual levels at each time point

3

2

1

0

mm

2.8

1.8

Membrane Emdogain®

p = 0.033

Clinical evidence

Clinical evidence in furcation defects¹

Study Design Randomized, controlled, prospective, split-mouth, multi-center clinical trial

Population 45 patients with contralateral furcations (90 furcations in total)

Modalities Emdogain®

Collagen membrane

Results Significantly greater reduction in horizontal furcation depth with Emdogain®

Lower incidence of pain and swelling when Emdogain® was used

(at re-entry at 14 months post-op)

Median reduction of horizontal furcation with interquartile interval

1 A randomized clinical trial comparing enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars. Part I: Study design and results for primary outcomes. Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J. J Periodontol. 2004 Aug;75(8):1150-60.

Membrane Emdogain®

1w 2w 3w

0

10

20

30

40

50

60

70

80

29%35%

62%

GTR Emdogain®

0

20

40

60

80

100

6%

100%

Clinical evidence

Less complications compared to membranes¹

Study Design Randomized, controlled, prospective, multi-center clinical trial

Population 75 patients, each with at least 1 intrabony defect of ≥ 3 mm

Modalities Emdogain®

Collagen membrane

Results Both treatment modalities performed similarly

All sites treated with a membrane had a complication, either 1, 2 or 3 weeks after treatment whereas only 6 % had such issues in the Emdogain® group

Rate of appearance of membrane exposure in GTR after 1, 2 and 3 weeks in the GTR group

Complication rate (lack of primary closure, flap dehiscence, membrane exposure, suppuration) after 9 weeks with GTR or Straumann® Emdogain®1 Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P,

Suvan JE. Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter practice-based clinical trial. J Periodontol. 2004 May;75(5):726-33.

1w 2w 3w

0

10

20

30

40

50

60

70

80

29%35%

62%

CTG+CAF Emdogain®+ CAF

78%

0%0

20

40

60

80

100

Percentage of teeth with regeneration*

CTG+CAF Emdogain®+ CAF

78%

0%0

20

40

60

80

100

Percentage of teeth with regeneration*

CTG+CAF Emdogain®+ CAF

78%

0%0

20

40

60

80

100

Percentage of teeth with regeneration*

Clinical evidence

Human histological evi-dence of true regeneration – recession defects¹

Study Design Randomized, open-label study

Population 3 patients, 12 teeth

Modalities Emdogain® + Coronally Advanced Flap (CAF)

Connective Tissue Graft (CTG) + CAF

Results Regeneration* in all three patients in the Emdogain® + CAF group

Lack of regeneration** in all three patients in the CTG + CAF group

*formation of new cementum, periodontal ligament and bone**formation of long junction epithelium

1 McGuire MK, Scheyer ET, Schupbach P. A Prospective, Cased-Controlled Study Evaluating the use of Enamel Matrix Derivative on Human Buccal Recession Defects: A Human Histologic Examination. J Periodontol. 2016 Feb 1:1-34.

Dr. Gunnar HedenKarlstadt, Sweden

Prof. Dr. Giovanni ZucchelliUniversity of Bologna, Italy

Dr. David NisandParis, France

Clinical cases

Pictures courtesy of Dr. Gunnar Heden, Karlstadt, Sweden

Pre-op 8 years post-op

Clinical cases

Dr. Gunnar Heden – Long-term clinical case in intrabony defects

Pictures courtesy of Prof. Giovanni Zucchelli, University of Bologna, Italy

8 months post-treatment with CAF and Emdogain®

7 years post-treatment with CAF and Emdogain®

Before treatment

Clinical cases

Prof. Dr. Giovanni Zucchelli – Long-term clinical case in gum recession defects

Pictures courtesy of Dr. David Nisand, Paris, France

Pre-op 2 years post-op

Clinical cases

Dr. David Nisand – Long-term clinical case in furcation defects

Using Straumann® Emdogain®

• Helps achieving predictable results in your periodontal surgery and recession coverage procedures

• Leads to patient satisfaction thanks to better tooth prognosis, less pain and swelling and to esthetic results

• Shows less complications compared to membranes

Summary

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