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Straumann ® Emdogain May 25, 2011

Straumann · PDF filefindings, results, studies predominantly on Straumann® Emdogain or other Straumann products ... Classification of the recession defects Miller Class I II III

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Straumann® Emdogain

May 25, 2011

STRAUMANN®

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2

Please note that this Straumann® Scientific Evidence Presentation File (“File”) contains a selection of studies and makes no claim to be a complete study list. Articles were selected on merit from the results of a literature search.

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Straumann®

Emdogain

Recession Defects Intrabony DefectsFurcation DefectsLong-term Data

Recession defectsMay 25, 2011

Straumann® Emdogain

STRAUMANN® 5Miller PD Jr.Int J Periodontics Restorative Dent. 1985;5(2):8-13.A classification of marginal tissue recession

Classification of the recession defects

Miller Class I II III IV

Relation to mucogingival junction

Recession does not reach the mucogingival junction

Recession reaches or goes beyond the mucogingival junction

Recession reaches or goes beyond the mucogingival junction

Recession reaches or goes beyond the mucogingival junction

Bone loss in interdental area, tooth malposition

Neither Neither One or both One or both (severe)

Expected root coverage

100% 100% Partial None

STRAUMANN® 6

Straumann® EmdogainPublication First AuthorFirst Author Full Author List Full Title Reference

1 McGuire MK McGuire MK, Nunn M.Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue. Part 1: Comparison of clinical parameters

J Periodontol. 2003 Aug;74(8):1110-25.

2 Cueva MACueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.

A comparative study of coronally advanced flaps with and without the addition of enamel matrix derivative in the treatment of marginal tissue recession

J Periodontol. 2004 Jul;75(7):949-56.

3 Spahr A

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique: a 2-year report.

J Periodontol. 2005 Nov;76(11):1871-80.

4 Castellanos A Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions J Periodontol. 2006 Jan;77(1):7-14

jump to Study ! jump to Ref !

Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix

derivative or connective tissue. Part 1: Comparison of clinical parameters

McGuire MK, Nunn M.J Periodontol. 2003 Aug;74(8):1110-25.

STRAUMANN® 8McGuire MK, Nunn M.J Periodontol. 2003 Aug;74(8):1110-25.

Goal• To compare the clinical outcome of recession defects treated with the

coronally advanced flap technique (CAF) and either Emdogain or subepithelial connective tissue graft (CTG)

Methodology• Randomized, controlled clinical trial

• 20 patients

• Miller’s Class II buccal gingival recession of ≥ 4mm and width ≥ 3mm

• Incisors or premolars in contralateral quadrants of the same jaw

• Treatments sites were randomized in the control (coronally advanced flap with subepithelial connective tissue graft) or test group (coronally advanced flap with Emdogain) according to a split mouth design

Evaluation of human recession defects: comparison of clinical parameters

STRAUMANN® 9

Results

• The patient reported discomfort was found to be significantly lower when Emdogain was used (one out of ten) compared to connective tissue alone (nine out of ten)

Evaluation of human recession defects: comparison of clinical parameters

0

3

6

9

CAF + CTG CAF + Emdogain

Num

ber

of p

atie

nts

Discomfort levels reported by patients at one month after surgery

✽ p<0.01

McGuire MK, Nunn M.J Periodontol. 2003 Aug;74(8):1110-25.

STRAUMANN® 10

Results

Evaluation of human recession defects: comparison of clinical parameters

McGuire MK, Nunn M.J Periodontol. 2003 Aug;74(8):1110-25.

• A higher frequency of sites showing complete coverage of the root was found in the group treated with CAF + Emdogain compared to the CAF + CTG group

70

75

80

85

90

CAF + CTG CAF + Emdogain

Com

ple

te r

oot

cove

rage

(%)

Incidence of complete root coverage (100% of coverage)

79.0%

89.5%

STRAUMANN® 11

• The addition of Emdogain to the coronally advanced flap resulted in a root coverage similar to the subepithelial connective tissue graft, but without the morbidity due to potential clinical difficulties associated with the donor site surgery

Conclusion

Evaluation of human recession defects: comparison of clinical parameters

McGuire MK, Nunn M.J Periodontol. 2003 Aug;74(8):1110-25.

A comparative study of coronally advanced flaps with and without the addition of Enamel matrix derivative in

the treatment of marginal tissue recession

Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

STRAUMANN® 13Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

A comparative study of coronally advanced flaps in the treatment of marginal tissue recession

Goal

• To compare the clinical outcomes of root coverage procedures using the coronally advanced flap (CAF) technique with and without Emdogain

• To evaluate the influence of Emdogain on tissue keratinization

Methodology

• Randomized, controlled clinical trial

• 17 patients

• Miller’s Class I,II and III buccal marginal tissue recession ≥ 2mm

• 58 contralateral sites treated in total (29 sites per treatment modus)

• Treatment sites were randomized in the control (CAF alone) or test group (CAF in combination with Emdogain) according to a split mouth design

STRAUMANN® 14

Results

• The vertical and the horizontal recessions showed significantly lower values after treatment with CAF + Emdogain compared to CAF alone (both at 3 and 6 months)

• CI = Confidence interval

0

1.3

2.5

3.8

5.0

Ad

just

ed m

ean

and

95%

CI (

mm

)

CAFCAF + Emdogain

Horizontal RecessionVertical Recession

✽ ✽

Clinical outcomes 3 and 6 months after surgery

✽ p < 0.05

Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

A comparative study of coronally advanced flaps in the treatment of marginal tissue recession

Baseline 3 months 6 months Baseline 3 months 6 months

0

2.5

5.0

7.5

10.0

Baseline 3 months 6 months

STRAUMANN® 15

Results

✽ p < 0.05

• The analysis of the root exposure showed a significantly higher coverage in the CAF + Emdogain group compared to CAF alone

Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

A comparative study of coronally advanced flaps in the treatment of marginal tissue recession

Clinical outcomes at 3 and 6 months after surgery

✽ p < 0.05

Exp

osed

roo

t su

rfac

e ar

ea (a

dju

sted

m

ean

and

95%

CI,

mm

2 )

0

25

50

75

100

3 months 6 months

CAFCAF + Emdogain

✽✽

✽ p < 0.05

% R

oot

cove

rage

(ad

just

ed m

ean

and

95%

CI,

mm

)

CAFCAF + Emdogain

0

0.8

1.5

2.3

3.0

Baseline 6 months

CAFCAF + Emdogain

STRAUMANN® 16

Results

Change of keratinized tissue values over time

✽ p < 0.05

Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

A comparative study of coronally advanced flaps in the treatment of marginal tissue recession

• The values for keratinized tissue were significantly higher after 6 months when CAF was used in conjunction with Emdogain

Ker

atin

ized

tis

sue

(ad

just

ed m

ean

and

95

% C

I, m

m)

STRAUMANN® 17

Conclusions

• The application of Emdogain to denuded root surfaces treated with the CAF technique increased significantly the percentage of root coverage compared to CAF alone

• The application of Emdogain was accompanied by a significant increase in keratinized tissue six months after surgery

Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T.J Periodontol. 2004 Jul;75(7):949-56.

A comparative study of coronally advanced flaps in the treatment of marginal tissue recession

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap

technique: a 2 year report

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.

J Periodontol. 2005 Nov;76(11):1871-80.

STRAUMANN® 19

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.J Periodontol. 2005 Nov;76(11):1871-80.

Goal

• To compare the coronally advanced flap procedure used in the treatment of recession defects with or without the addition of Emdogain

Methodology

• Randomized, placebo-controlled, blinded clinical study

• 30 patients

• Miller Class I and II buccal recession defects ≥ 3mm in contralateral quadrants of the same jaw

• Surgical recession coverage was performed according to the coronally advanced flap technique

• Emdogain (test) or placebo (propylene glycol alginate, control) were randomly assigned to the sites according to a split-mouth design

STRAUMANN® 20

Results

• The decrease in REC width and PPD were shown to be significantly greater when Emdogain was used compared to placebo

Reduction in recession width (REC width) and pocket probing depth (PPD) 2 years

after surgery

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.J Periodontol. 2005 Nov;76(11):1871-80.

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique

0

1.3

2.5

3.8

5.0

REC width PPD

Mea

n re

duc

tion

(mm

)

PlaceboEmdogain

✽ p < 0.03

✽ p < 0.04

STRAUMANN® 21

Results

0

15

30

45

60

Emdogain Placebo

Com

ple

te r

oot

cove

rage

(%)

0

13

25

38

50

Emdogain Placebo

Det

erio

rate

d t

reat

ed r

eces

sion

s (%

)

Percentage of complete root coverage 2 years after surgery

Percentage of treated recession that deteriorated in the second year after therapy

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.J Periodontol. 2005 Nov;76(11):1871-80.

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique

53%

23%22%

47%

STRAUMANN® 22

Conclusion

There is indication that the addition of Emdogain to the CAF technique...• provides better long-term results concerning the stability of the treatment• increases the amount of complete root coverage 2 years after surgery• reduces the amount of deteriorated recessions in the second year after therapy...in comparison to the CAF technique alone

Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B.J Periodontol. 2005 Nov;76(11):1871-80.

Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions

Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.J Periodontol. 2006 Jan;77(1):7-14.

STRAUMANN® 24

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions

Goal

• To clinically evaluate the use of Emdogain in association with coronally positioned flap (CPF) technique to cover localized gingival recessions compared to CPF alone

Methodology

• Randomized, controlled clinical study

• 22 patients

• Miller Class I and II gingival recession defects > 2mm

• Control group: CPF alone; test group: CPF in combination with Emdogain

• Surgical recession coverage was performed according to the “coronally positioned flap” (CPF) technique

Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.J Periodontol. 2006 Jan;77(1):7-14.

Results

STRAUMANN® 25

0

1.3

2.5

3.8

5.0

Baseline 6 months 12 months

Vert

ical

rec

essi

on (m

m)

Emdogain + CPFCPF

0

1.8

3.5

5.3

7.0

Baseline 6 months 12 monthsH

oriz

onta

l rec

essi

on (m

m)

Emdogain + CPFCPF

✽ ✽✽ ✽

✽ p < 0.05✽ p < 0.05

Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.J Periodontol. 2006 Jan;77(1):7-14.

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions

Vertical and horizontal recessions 6 and 12 months after surgery

• The vertical and horizontal recessions significantly improved after 6 and 12 months when Emdogain was used in conjunction with CPF

STRAUMANN® 26

Results

Emdogain + CPFCPF

0

1.8

3.5

5.3

7.0

Baseline 12 months

Ker

atin

ized

gin

giva

(mm

)

✽ p < 0.05

Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.J Periodontol. 2006 Jan;77(1):7-14.

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions

• The addition of Emdogain resulted in a statistically significantly higher value after 12 months for the keratinized gingiva

Keratinized gingiva 12 months after surgery

STRAUMANN® 27

The addition of Emdogain to the CPF technique...

• significantly improved the amount of root coverage of localized gingival recessions

• resulted in a statistically significantly higher keratinized gingiva value after 12 months

...in comparison to the CPF technique alone

Conclusion

Castellanos A, de la Rosa M, de la Garza M, Caffesse RG.J Periodontol. 2006 Jan;77(1):7-14.

Enamel matrix derivative and coronal flaps to cover marginal tissue recessions

Intrabony defectsMay 25, 2011

Straumann® Emdogain

STRAUMANN® 29Goldman, HM, Cohen, DW. The infrabony pocket. Classification and treatment. J Periodontol, 29:272, 1958

Classification of the intrabony defects

A 1-wall intrabony defect is bordered by a tooth surface, one interproximal osseous surface and soft tissue

A 2-wall intrabony defect is bordered by a tooth surface and two osseous surfaces (one interproximal and one buccal or lingual)

A 3-wall intrabony defect is bordered by one tooth surface and tree osseous surfaces

Note: The graphic depicts different modes of visual explanation for bony defects and can not be directly compared

STRAUMANN® 30

Straumann® EmdogainPublication First AuthorFirst Author Full Author List Full Title Reference

1 Froum SJ Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.

A comparative study utilizing open flap debridement with and without enamel matrix derivative in the treatment of periodontal intrabony defects: a 12-month re-entry study

J Periodontol. 2001 Jan;72(1):25-34.

2 Tonetti MS

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.

3 Sanz M

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.

4 Francetti LFrancetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects: a 24-month multicenter study.

Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

5 Crea A Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G.

Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative: a 3-year prospective randomized clinical study J Periodontol. 2008 Dec;79(12):2281-9

jump to Study ! jump to Ref !

A comparative study utilizing open flap debridment with and without enamel matrix derivative in the treatment of

periodontal intrabony defects: a 12-months re-entry study

Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.J Periodontol. 2001 Jan;72(1):25-34.

STRAUMANN® 32Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.J Periodontol. 2001 Jan;72(1):25-34.

Goal

• To compare at 12 months post surgery sites treated with open flap debridement (OFD) alone to those treated with OFD and Emdogain

Methodology

• Randomized, controlled clinical trial

• 23 patients with at least 2 intrabony defects

• 53 defects were treated with OFD and Emdogain, 31 defects were treated with Emdogain alone

•The defects were randomly assigned to the treatment groups according to a split mouth design

A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study

Reduction in probing depth

Clinical attachment level gain

Amount of defect fill

0 1.50 3.00 4.50 6.00

Adjusted mean and 95% CI (mm)

Control - OFD aloneTest - OFD with Emdogain

Means were adjusted for baseline measures of probing depth or osseous depth

STRAUMANN® 33

Results

• For all three clinical parameters analyzed, the addition of Emdogain resulted in statistically significantly higher values compared to OFD alone

Adjusted mean changes in clinical parameters 12 months after surgery

Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.J Periodontol. 2001 Jan;72(1):25-34.

A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study

✽ p<0.01

STRAUMANN® 34

Results

• When Emdogain was used in conjunction with OFD, the percentage of defect fill was more than 3 times higher compared to the treatment with OFD alone

Adjusted mean changes in percentage of defect fill 12 months after surgery

Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.J Periodontol. 2001 Jan;72(1):25-34.

A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study

Means were adjusted for baseline measures of probing depth or osseous depth

0

20

40

60

80

OFD OFD + Emdogain

% o

f def

ect

fill

✽ p<0.01

22.7%

74.0%

STRAUMANN® 35

• The study indicated that the treatment of periodontal intraosseous defects with OFD in combination with Emdogain is clinically superior to the treatment with OFD alone when considering the reduction in probing depth, the clinical attachment level gain and the amount of defect fill

Conclusion

Froum SJ, Weinberg MA, Rosenberg E, Tarnow D.J Periodontol. 2001 Jan;72(1):25-34.

A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

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.J Clin Periodontol. 2002 Apr;29(4):317-25.

STRAUMANN® 37Tonetti 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.J Clin Periodontol. 2002 Apr;29(4):317-25.

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

Goal• To compare the clinical outcome of the papilla preservation flap technique with or

without the application of Emdogain

Methodology• Randomized, controlled, multicenter clinical trial (12 centers in 7 countries)

• 172 patients with chronic periodontitis were enrolled in the study. Data from 166 patients were collected at the one year follow-up

• Patients had at least one intrabony defect ≥ 3mm

• The surgical procedures included either the Simplified Papilla Preservation Flap (SPPF, if the interproximal space measured at the interproximal soft tissue had a mesio-distal width ≤ 2mm ) or the Modified Papilla Preservation Flap (MPPF, if the space was >2 mm ) techniques

• Patients in the control group were treated with the SPPF or MPPF technique only, while in the test group the surgeries were performed in conjunction with Emdogain

STRAUMANN® 38

Results

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

The additional use of Emdogain • led to a significantly higher gain

in CAL • a greater decrease in PPD

compared to the treatment with SPPF/MPPF alone

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.J Clin Periodontol. 2002 Apr;29(4):317-25.

Clinical outcomes 1 year after treatment for the two treatment groups

0

2

4

6

SPPF/MPPF + Emdogain (n=83)

SPPF/MPPF (n=83)

Gain in clinical attachment level

(CAL)

Decrease in pocket probing depth

(PPD)

mm

✽ p < 0.05

STRAUMANN® 39

Results

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

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.J Clin Periodontol. 2002 Apr;29(4):317-25.

Frequency distribution (%) of sites showing loss or gain of Clinical Attachment Level (CAL) subdivided in categories (1 year after surgery)

Frequency distribution (%) of sites showing loss or gain of Clinical Attachment Level (CAL) subdivided in categories (1 year after surgery)

Frequency distribution (%) of sites showing loss or gain of Clinical Attachment Level (CAL) subdivided in categories (1 year after surgery)

Frequency distribution (%) of sites showing loss or gain of Clinical Attachment Level (CAL) subdivided in categories (1 year after surgery)

Frequency distribution (%) of sites showing loss or gain of Clinical Attachment Level (CAL) subdivided in categories (1 year after surgery)

CAL loss CAL gain

0-1 mm 2-3 mm ≥4 mm

SPPF/MPPF + Emdogain 1.2 9.9 50.6 38.3

SPPF/MPPF 2.6 17.9 59.0 20.5

• The percentage of sites showing CAL loss were 2.2 times less frequent when Emdogain was added to the treatment compared to the surgery alone

• In the group treated with Emdogain, the percentage of sites displaying a CAL gain ≥ 4mm was almost 2 times higher compared to the surgery only-group

STRAUMANN® 40

• The regenerative periodontal surgery (papilla preservation technique) used in combination with Emdogain offers an additional benefit in terms of CAL gain and PPD reduction compared with the surgical technique alone

Conclusions

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

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.J Clin Periodontol. 2002 Apr;29(4):317-25.

Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a

multicenter practice-based clinical trial

Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE.

J Periodontol. 2004 May;75(5):726-33.

STRAUMANN® 42

Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial

Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE.J Periodontol. 2004 May;75(5):726-33.

Goal

• To compare the clinical outcomes of Emdogain versus placement of bioabsorbable membrane in conjunction with guided tissue regeneration (GTR)

Methodology

• Randomized, controlled, multicenter clinical trial

• 7 centres in 3 countries

• 75 patients with advanced chronic periodontitis

• Patients displayed intrabony defect of ≥ 3mm located in the anterior and premolar region

• One defect per patient was treated using the simplified papilla preservation flap (PPF) and either the application of Emdogin (test) or the placement of a membrane according to GTR (control)

0

25

50

75

100

Emdogain GTR

% p

atie

nts

rep

ortin

g co

mp

licat

ions

Percentages of patients reporting complications in the Emdogain and

GTR groups

✽ p < 0.01

STRAUMANN® 43

Results

• The number of patients reporting complications in the Emdogain group were limited to 6%, while all the patients treated with GTR reported at least one complication

• The complications reported by the patients of the GTR group were mostly membrane exposure

Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE.J Periodontol. 2004 May;75(5):726-33.

Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial

STRAUMANN® 44

Results

0

1

2

3

4

5

CA

L ga

in (m

m)

Emdogain GTR

Gain in clinical attachment level (CAL) 1 year after surgery

Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE.J Periodontol. 2004 May;75(5):726-33.

Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial

• Both treatments led to good results in terms of CAL gain:

✓ Emdogain: 3.1 ± 1.8 mm

✓ GTR: 2.5 ± 1.9 mm

STRAUMANN® 45

• Emdogain and GTR in conjunction with the papilla preservation flap technique led to significant improvements after one year

• Patients treated with GTR showed a higher frequency of postoperative complications (mostly membrane exposure) compared with the treatment using Emdogain

Conclusion

Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE.J Periodontol. 2004 May;75(5):726-33.

Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects: a 24-month multicenter

study

Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.

Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

STRAUMANN® 47Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects

Goal• To evaluate the efficacy of Emdogain when combined with surgical treatment of

periodontal angular defects as compared to surgery alone

Methodology• Randomized, controlled, multicenter clinical trial

• 17 centers in Italy

• 153 patients enrolled, accounting for 195 defects

• One-, two- and three-wall angular defects were included

• Intrabony defect depth was ≥ 4mm and probing procket depth was ≥ 6mm

• Surgical technique: simplified papilla preservation flap (SPPF), used in combination with Emdogain (test) or alone (control)

STRAUMANN® 48

Results

12 41

• At 12 and 24 months after treatment a significantly higher value for the gain in periodontal attachment level (PAL) was observed in the Emdogain + SPPF group compared to the SPPF group alone

Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects

0

10

20

30

40

12 months 24 months

PAL

gain

(%)

Emdogain + SPPFSPPF

Periodontal attachment level (PAL) gain with respect to baseline

✽ ✽

✽ p<0.01

38.2% 39.4%

24.6%

31.5%

STRAUMANN® 49

Results

• The percentage of IBD gain one year after surgery was 1.5 times higher when Emdogain was used in addition to SPPF compared to SPPF alone. All defects were included in this analysis irrespective of their depth

Intrabony defect depth (IBD) with respect to baseline 1 year after treatment

0

15

30

45

60

Emdogain + SPPF SPPF

IBD

gai

n* (%

) 53.7%

35.4%

✽ p<0.01

Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects

*IBD gain indicates the change with respect to the baseline expressed in %

STRAUMANN® 50

Results

• Also in case of deep defects (> 6mm) the addition of Emdogain leads to a greater (1.65 times) percentage of IBD gain compared to SPPF alone

Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects

0

14

28

42

56

70

Emdogain + SPPF SPPF

IBD

gai

n* (%

)

Intrabony defect depth (IBD) with respect to baseline 1 year after treatment for deep defects (> 6mm)

✽ p<0.05

60.1%

36.4%

*IBD gain indicates the change with respect to the baseline expressed in %

STRAUMANN® 51

• The use of Emdogain significantly improved the periodontal attachment level (PAL) gain with respect to baseline as well as the gain in intrabony defect depth (IBD) with respect to baseline one year after treatment as compared to the use of the surgical technique alone

• Emdogain demonstrated better results in terms of improvement in intrabony defect depth (IBD) with respect to baseline one year after treatment when it was used in the subgroup of deeper defects (> 6mm) compared to the results obtained with the surgery alone

Conclusions

Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, Del Fabbro M.Int J Periodontics Restorative Dent. 2005 Oct;25(5):461-73.

Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects

Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative: a 3-year

prospective randomized clinical study

Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G.J Periodontol. 2008 Dec;79(12):2281-9.

STRAUMANN® 53

Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative

Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G.J Periodontol. 2008 Dec;79(12):2281-9.

Goal

• To compare the clinical results obtained with guided tissue regeneration (GTR) to the ones obtained with Emdogain in the treatment of intrabony defects

Methodology

• Randomized, controlled clinical trial

• 40 patients with advanced chronic periodontitis

• 40 defect, exclusively 3-wall defects, each with a depth ≥4mm

• Surgical technique: simplified papilla preservation flap (SPPF), used in combination with Emdogain (test) or non-resorbable membranes (control)

STRAUMANN® 54

Results

• The treatment with Emdogain showed significantly higher values for CAL gain compared to GTR one and three years after surgery

0

1

2

3

4

5

1 year 3 year

CA

L ga

in (m

m)

EmdogainGTR

Clinical attachment level (CAL) gain 1 and 3 years after surgery

✽ p<0.01

Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G.J Periodontol. 2008 Dec;79(12):2281-9.

Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative

STRAUMANN® 55

• The gain of clinical attachment level at 12 and 36 months after surgery was significantly higher when the defects were treated with Emdogain compared to the treatment with GTR

Conclusion

Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G.J Periodontol. 2008 Dec;79(12):2281-9.

Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative

Furcation defectsMay 25, 2011

Straumann® Emdogain

STRAUMANN® 57Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975;2:126-35

Classification of the furcation defects

Class/degree ISmall furcation defect: the furcation opening is determined by probing. The horizontal loss of supporting tissue does not exceed 1/3 of the width of the tooth

Class/degree IILarge furcation defect: it is possible to probe deep into the furcation. However, the probe does not go all the way through. There is a horizontal loss of supporting tissue exceeding 1/3 of the width of the tooth. The bone loss in class II defects is often visible on radiographs

Class/degree III „Through-and-through“ furcation defect: indicates a loss of all supporting periodontal tissues in the furcation. The probe goes all the way through

STRAUMANN® 58

Straumann® EmdogainPublication First AuthorFirst Author Full Author List Full Title Reference

1 Jepsen S

Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J.

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

J Periodontol. 2004 Aug;75(8):1150-60.

jump to Study ! jump to Ref !

A randomized clinical trial comparing Enamel Matrix Derivative and membrane treatment of buccal class II

furcation involvement in madibular molars. Part I: study design and results for primary outcome

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.

STRAUMANN® 60Jepsen 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.

Goal• To compare Emdogain with bioabsorbable barrier membranes for the treatment

of mandibular buccal class II furcation defects

Methodology• Randomized, controlled, multicenter clinical trial

• 45 patients

• 90 buccal Class II furcation defects on contralateral molars

• Horizontal probing depth >3mm

• Defects were randomly assigned to the Emdogain or the guided tissue regeneration (GTR) group according to a split-mouth design

Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars

STRAUMANN® 61

Results

0

5

10

15

20

Emdogain GTR

% d

efec

ts

18%

7%

Frequency of furcation defects completely closed 14 months after surgery

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.

Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars

• The percentage of completely closed furcation defects in the Emdogain group was 2.6 times higher than in the GTR group

STRAUMANN® 62

Results

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.

Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars

Incidence of post-operative pain and swelling one week after surgery

0

25

50

75

100

Pain Swelling

% p

atie

nts

Emdogain GTR

87.5

56.3

93.8

37.5

• The percentage of patients reporting pain and swelling was 2.3 and 1.7 times higher, respectively, in the GTR group compared to the Emdogain group

STRAUMANN® 63

• The application of Emdogain resulted in a significantly higher percentage of completely closed furcation defects compared to the use of standard membrane in the treatment of buccal mandibular Class II defects

• The study showed that fewer adverse events and postoperative complications during the early healing period were found with the use of Emdogain resulting in less discomfort for the patient

Conclusions

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.

Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars

Long-term data May 25, 2011

Straumann® Emdogain

Sun

January, 2011January, 2011January, 2011

Mon Tue Wed Thu Fri Sat

2

9

16

23

27 28 29 30 31 1

3 4 5 6 7 8

10 11 12 13 14 15

17 18 19 20 21 22

24 25 26 27 28 29

STRAUMANN® 65

Straumann® EmdogainPublication First AuthorFirst Author Full Author List Full Title Reference

1 Heden G Heden G, Wennström JL Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects. J Periodontol. 2006 Feb;77(2):295-301.

2 Sculean ASculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M.

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

jump to Study ! jump to Ref !

Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bony

defects

Heden G, Wennström JLJ Periodontol. 2006 Feb;77(2):295-301.

STRAUMANN® 67Heden G, Wennström JLJ Periodontol. 2006 Feb;77(2):295-301.

Goal• To analyze the long-term stability of clinical attachment level gain following

regenerative therapy with the use of Emdogain in intrabony defects

Methodology• Case series report

• 82 patients with at least one deep proximal intrabony defect

• 102 defects included in the analysis

• Defect probing depth ≥5mm, clinical attachment loss ≥6mm, radiographic intrabony component ≥3mm

Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects

-6.0

-4.5

-3.0

-1.5

0

Mea

n an

d 9

5% C

I (m

m)

Probing depth (PD)Clinical attachment level (CAL)

STRAUMANN® 68

Results

• When PD and CAL are followed over time, the change in each parameter is significant between baseline and one year (data not shown), while it is not when the comparison is made between 1 and 5 years, indicating the maintenance of the clinical parameters in the long term

1 year 5 years

Clinical stability of intrabony defects treated with Emdogain at 1 and 5 years

Heden G, Wennström JLJ Periodontol. 2006 Feb;77(2):295-301.

Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects

STRAUMANN® 69

• The use of Emdogain intrabony defects demonstrated 5-years-stability of clinical attachment level (CAL) gain and probing depth (PD) recession following regenerative therapy

Conclusion

Heden G, Wennström JLJ Periodontol. 2006 Feb;77(2):295-301.

Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects

Ten-year results following treatment of intrabony defects with enamel matrix proteins and guided tissue

regeneration

Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M.J Clin Periodontol. 2008 Sep;35(9):817-24.

STRAUMANN® 71Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M.J Clin Periodontol. 2008 Sep;35(9):817-24.

Goal• To evaluate the 10-year results of intrabony defects treated with:

i) Emdogainii) guided tissue regeneration (GTR)iii) the combination of Emdogain and GTRiv) the open flap debridment (OFD) technique

Methodology• Randomized, controlled clinical trial

• 38 patients displaying one intrabony defect

• Probing depth of the defects was ≥6mm

• Randomized assignment of the patients to one of the 4 treatment group

• The patients included in this study were those who regularly attended the maintenance care program (four visits a year, including oral hygiene reinforcement and professional tooth cleaning)

Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration

STRAUMANN® 72

Results

0

1

2

3

4

5

EMD EMD + GTR GTR OFD

CA

L ga

in (m

ean

± S

D, m

m)

1 year10 years

Clinical attachment level (CAL) values remain stable up to 10 years after treatment with Emdogain• In each of the treatment group the

values for CAL gain are not statistically different when the data of 1 and 10 years are compared. This indicates that the clinical outcome remains stable over the years

• Compared to OFD, the treatments with Emdogain, GTR and Emdogain+GTR showed a significantly higher CAL gain both at 1 and 10 years (p<0.05)

Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M.J Clin Periodontol. 2008 Sep;35(9):817-24.

Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration

n = 10 n = 10n = 9

n = 9

n = number of patients

STRAUMANN® 73

• The results of this long-term study indicate that the good clinical results obtained with Emdogain are stable and can be maintained over a period of 10 years

Conclusion

Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M.J Clin Periodontol. 2008 Sep;35(9):817-24.

Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration