Straumann Emdogain May 25, 2011

Transcription

1 Straumann Emdogain May 25, 2011

2 Terms and Conditions of Institut Straumann AG regarding the use of the presentations contained in this Emdogain Scientific Evidence Presentation File 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. By using this File, in whole or in part, the customer who has received the File from Institut Straumann AG ( User ), implicitly agrees to the following terms and conditions ( Terms and Conditions ): 1. The studies contained in this File were made by independent researchers. Whenever the User uses information from this File, the User shall cite the references in a clear and appropriate manner. Furthermore, the User shall comply with all applicable laws and regulations. 2. The User is allowed to use the File for the sole and limited purpose of holding presentations ( Presentation ) to inform the public of new data, findings, results, studies predominantly on Straumann Emdogain or other Straumann products ( Straumann Products ). 3. The User shall not use the File for any purpose other than the Presentation, and the User agrees that any such use shall be consistent with all applicable laws and regulations and highest professional standards. 4. The User represents and warrants that to the best of his/her knowledge the content of the Presentation is true and correct and does not include any illegal, unethical or offensive contents and that all statements made in the Presentation are within indications of the Straumann Products (refer to Instructions for Use) and the User shall refrain from promoting any off-label use. 5. The User may take separate slides from this File, but shall not alter the content of a slide. 6. The User agrees that Institut Straumann AG shall have the right to terminate this agreement (Terms and Conditions) at any time upon five (5) days written notice, for any reason or no reason whatsoever, and the User agrees that upon receiving such notice, he/she shall cease the distribution of and destroy any materials containing information from this File. 7. While Institut Straumann AG is making great efforts to include accurate and up-to-date information in the File, Institut Sraumann AG makes no representations or warranties, express or implied, as to the accuracy or completeness of the information provided in this File. Institut Straumann AG and its affiliates and subsidiaries disclaim any liability for the use of the File and shall not be liable in any manner for any direct, incidental, consequential, indirect or punitive damages arising out of the use of the File or any errors or omissions in the content thereof. The User agrees that he/she shall not be entitled to recover any costs, fees, damages, or other sums from Institut Straumann AG and / or its affiliates and / or subsidiaries for any claim relating to or arising out of the permission granted in these Terms and Conditions. 8. The User agrees that he/she will not permit the use of the File, in full or in part, by any third party without the prior written consent of Institut Straumann AG, and that doing so will be deemed a violation of these Terms and Conditions. 9. The User is not permitted to assign the rights and obligations under these Terms and Conditions to any other party without the prior written consent of Institut Straumann AG. STRAUMANN 2 All trademarks from Straumann mentioned herein are the trademarks of Straumann Holding AG and/or its affiliates.

3 Straumann Emdogain Recession Defects Intrabony Defects Furcation Defects Long-term Data

4 Straumann Emdogain Recession defects May 25, 2011

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

6 Straumann Emdogain Publication First 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 Aug;74(8): Cueva MA Cueva 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 Jul;75(7): 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 Nov;76(11): 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 Jan;77(1):7-14 jump to Study! jump to Ref! STRAUMANN 6

7 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 Aug;74(8):

8 Evaluation of human recession defects: comparison of clinical parameters 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 McGuire MK, Nunn M. STRAUMANN J Periodontol Aug;74(8):

9 Evaluation of human recession defects: comparison of clinical parameters Results Discomfort levels reported by patients at one month after surgery Number of patients p<0.01 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) 0 CAF + CTG CAF + Emdogain McGuire MK, Nunn M. STRAUMANN J Periodontol Aug;74(8):

10 Evaluation of human recession defects: comparison of clinical parameters Results Incidence of complete root coverage (100% of coverage) Complete root coverage (%) % 89.5% 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 CAF + CTG CAF + Emdogain McGuire MK, Nunn M. STRAUMANN J Periodontol Aug;74(8):

11 Evaluation of human recession defects: comparison of clinical parameters Conclusion 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 McGuire MK, Nunn M. STRAUMANN J Periodontol Aug;74(8):

12 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 Jul;75(7):

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

14 A comparative study of coronally advanced flaps in the treatment of marginal tissue recession Results Clinical outcomes 3 and 6 months after surgery Vertical Recession Horizontal Recession Adjusted mean and 95% CI (mm) CAF CAF + Emdogain p < 0.05 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 Baseline 3 months 6 months Baseline 3 months 6 months Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T. STRAUMANN J Periodontol Jul;75(7):

15 A comparative study of coronally advanced flaps in the treatment of marginal tissue recession Results Clinical outcomes at 3 and 6 months after surgery Exposed root surface area (adjusted mean and 95% CI, mm 2 ) CAF CAF + Emdogain p < 0.05 Baseline 3 months 6 months % Root coverage (adjusted mean and 95% CI, mm) CAF CAF + Emdogain 3 months 6 months 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. STRAUMANN J Periodontol Jul;75(7):

16 A comparative study of coronally advanced flaps in the treatment of marginal tissue recession Results Change of keratinized tissue values over time CAF CAF + Emdogain p < 0.05 Keratinized tissue (adjusted mean and 95% CI, mm) Baseline 6 months The values for keratinized tissue were significantly higher after 6 months when CAF was used in conjunction with Emdogain Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T. STRAUMANN J Periodontol Jul;75(7):

17 A comparative study of coronally advanced flaps in the treatment of marginal tissue recession 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. STRAUMANN J Periodontol Jul;75(7):

18 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 Nov;76(11):

19 Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique 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 Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. 19 J Periodontol Nov;76(11):

20 Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique Results Reduction in recession width (REC width) and pocket probing depth (PPD) 2 years after surgery Mean reduction (mm) p < 0.03 p < 0.04 Placebo Emdogain The decrease in REC width and PPD were shown to be significantly greater when Emdogain was used compared to placebo 0 REC width PPD STRAUMANN Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. 20 J Periodontol Nov;76(11):

21 Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique Results Percentage of complete root coverage 2 years after surgery Percentage of treated recession that deteriorated in the second year after therapy Complete root coverage (%) % Emdogain 23% Placebo Deteriorated treated recessions (%) % Emdogain 47% Placebo STRAUMANN Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. 21 J Periodontol Nov;76(11):

22 Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique 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 STRAUMANN Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. 22 J Periodontol Nov;76(11):

23 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 Jan;77(1):7-14.

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 STRAUMANN Castellanos A, de la Rosa M, de la Garza M, Caffesse RG. 24 J Periodontol Jan;77(1):7-14.

25 Enamel matrix derivative and coronal flaps to cover marginal tissue recessions Results Vertical and horizontal recessions 6 and 12 months after surgery 5.0 Emdogain + CPF CPF 7.0 Emdogain + CPF CPF Vertical recession (mm) p < 0.05 Horizontal recession (mm) p < Baseline 6 months 12 months 0 Baseline 6 months 12 months The vertical and horizontal recessions significantly improved after 6 and 12 months when Emdogain was used in conjunction with CPF STRAUMANN Castellanos A, de la Rosa M, de la Garza M, Caffesse RG. 25 J Periodontol Jan;77(1):7-14.

26 Enamel matrix derivative and coronal flaps to cover marginal tissue recessions Results Keratinized gingiva 12 months after surgery p < Keratinized gingiva (mm) Emdogain + CPF CPF 0 Baseline 12 months The addition of Emdogain resulted in a statistically significantly higher value after 12 months for the keratinized gingiva STRAUMANN Castellanos A, de la Rosa M, de la Garza M, Caffesse RG. 26 J Periodontol Jan;77(1):7-14.

27 Enamel matrix derivative and coronal flaps to cover marginal tissue recessions Conclusion 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 STRAUMANN Castellanos A, de la Rosa M, de la Garza M, Caffesse RG. 27 J Periodontol Jan;77(1):7-14.

28 Straumann Emdogain Intrabony defects May 25, 2011

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

30 Straumann Emdogain Publication First 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 Jan;72(1): 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 Apr;29(4): 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 May;75(5): Francetti L Francetti 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 Oct;25(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 Dec;79(12): jump to Study! jump to Ref! STRAUMANN 30

31 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 Jan;72(1):25-34.

32 A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study 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 STRAUMANN Froum SJ, Weinberg MA, Rosenberg E, Tarnow D. 32 J Periodontol Jan;72(1):25-34.

33 A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study Results Adjusted mean changes in clinical parameters 12 months after surgery p<0.01 Reduction in probing depth Clinical attachment level gain Amount of defect fill Adjusted mean and 95% CI (mm) For all three clinical parameters analyzed, the addition of Emdogain resulted in statistically significantly higher values compared to OFD alone Means were adjusted for baseline measures of probing depth or osseous depth Control - OFD alone Test - OFD with Emdogain STRAUMANN Froum SJ, Weinberg MA, Rosenberg E, Tarnow D. 33 J Periodontol Jan;72(1):25-34.

34 A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study Results Adjusted mean changes in percentage of defect fill 12 months after surgery % of defect fill p< % 74.0% 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 0 OFD OFD + Emdogain Means were adjusted for baseline measures of probing depth or osseous depth STRAUMANN Froum SJ, Weinberg MA, Rosenberg E, Tarnow D. 34 J Periodontol Jan;72(1):25-34.

35 A comparative study utilizing open flap debridement with and without enamel matrix derivative: a 12-month re-entry study Conclusion 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 STRAUMANN Froum SJ, Weinberg MA, Rosenberg E, Tarnow D. 35 J Periodontol Jan;72(1):25-34.

36 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 Apr;29(4):

37 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 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. 37 J Clin Periodontol Apr;29(4):

38 Enamel matrix proteins in the regenerative therapy of deep intrabony defects Results Clinical outcomes 1 year after treatment for the two treatment groups SPPF/MPPF + Emdogain (n=83) SPPF/MPPF (n=83) mm p < 0.05 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 0 Gain in clinical attachment level (CAL) Decrease in pocket probing depth (PPD) STRAUMANN 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. 38 J Clin Periodontol Apr;29(4):

39 Enamel matrix proteins in the regenerative therapy of deep intrabony defects Results Frequency distribution (%) of sites showing loss or gain of Clinical Attachmentt Level (CAL) subdivided in categories (1 year after surgery) CAL loss CAL gain 0-1 mm 2-3 mm 4 mm SPPF/MPPF + Emdogain SPPF/MPPF 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 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. 39 J Clin Periodontol Apr;29(4):

40 Enamel matrix proteins in the regenerative therapy of deep intrabony defects Conclusions 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 STRAUMANN 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. 40 J Clin Periodontol Apr;29(4):

41 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 May;75(5):

42 Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial 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) STRAUMANN Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE. 42 J Periodontol May;75(5):

43 Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial Results % patients reporting complications Percentages of patients reporting complications in the Emdogain and GTR groups p < 0.01 Emdogain GTR 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 STRAUMANN Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE. 43 J Periodontol May;75(5):

44 Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial Results Gain in clinical attachment level (CAL) 1 year after surgery CAL gain (mm) Both treatments led to good results in terms of CAL gain: Emdogain: 3.1 ± 1.8 mm GTR: 2.5 ± 1.9 mm 0 Emdogain GTR STRAUMANN Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE. 44 J Periodontol May;75(5):

45 Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter clinical trial Conclusion 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 STRAUMANN Sanz M, Tonetti MS, Zabalegui I, Sicilia A, Blanco J, Rebelo H, Rasperini G, Merli M, Cortellini P, Suvan JE. 45 J Periodontol May;75(5):

46 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 Oct;25(5):

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

48 Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects Results Periodontal attachment level (PAL) gain with respect to baseline Emdogain + SPPF SPPF p<0.01 PAL gain (%) % 39.4% 31.5% 24.6% 12 months 24 months 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, STRAUMANN Del Fabbro M. Int J Periodontics Restorative Dent Oct;25(5):

49 Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects Results Intrabony defect depth (IBD) with respect to baseline 1 year after treatment IBD gain* (%) % p< % 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 0 Emdogain + SPPF SPPF *IBD gain indicates the change with respect to the baseline expressed in % Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, STRAUMANN Del Fabbro M. Int J Periodontics Restorative Dent Oct;25(5):

50 Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects Results Intrabony defect depth (IBD) with respect to baseline 1 year after treatment for deep defects (> 6mm) IBD gain* (%) % p< % 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 0 Emdogain + SPPF SPPF *IBD gain indicates the change with respect to the baseline expressed in % Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, STRAUMANN Del Fabbro M. Int J Periodontics Restorative Dent Oct;25(5):

51 Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects Conclusions 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 Francetti L, Trombelli L, Lombardo G, Guida L, Cafiero C, Roccuzzo M, Carusi G, STRAUMANN Del Fabbro M. Int J Periodontics Restorative Dent Oct;25(5):

52 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 Dec;79(12):

53 Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative 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 Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G. 53 J Periodontol Dec;79(12):

54 Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative Results Clinical attachment level (CAL) gain 1 and 3 years after surgery 5 Emdogain GTR p<0.01 CAL gain (mm) year 3 year The treatment with Emdogain showed significantly higher values for CAL gain compared to GTR one and three years after surgery STRAUMANN Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G. 54 J Periodontol Dec;79(12):

55 Treatment of intrabony defects using guided tissue regeneration or enamel matrix derivative Conclusion 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 STRAUMANN Crea A, Dassatti L, Hoffmann O, Zafiropoulos GG, Deli G. 55 J Periodontol Dec;79(12):

56 Straumann Emdogain Furcation defects May 25, 2011

57 Classification of the furcation defects Class/degree I Small 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 II Large 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 Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975;2:

58 Straumann Emdogain Publication First 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 Aug;75(8): jump to Study! jump to Ref! STRAUMANN 58

59 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 Aug;75(8):

60 Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars 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 STRAUMANN Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J. 60 J Periodontol Aug;75(8):

61 Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars Results Frequency of furcation defects completely closed 14 months after surgery % defects % 7% The percentage of completely closed furcation defects in the Emdogain group was 2.6 times higher than in the GTR group 0 Emdogain GTR STRAUMANN Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J. 61 J Periodontol Aug;75(8):

62 Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars Results Incidence of post-operative pain and swelling one week after surgery % patients Emdogain GTR 93.8 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 0 Pain Swelling STRAUMANN Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J. 62 J Periodontol Aug;75(8):

63 Enamel matrix derivative and membrane treatment of buccal Class II furcation involvement in mandibular molars Conclusions 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 STRAUMANN Jepsen S, Heinz B, Jepsen K, Arjomand M, Hoffmann T, Richter S, Reich E, Sculean A, Gonzales JR, Bödeker RH, Meyle J. 63 J Periodontol Aug;75(8):

64 Straumann Emdogain Sun January, 2011 Mon Tue Wed Thu Fri Sat Long-term data May 25, 2011

65 Straumann Emdogain Publication First 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 Feb;77(2): Sculean A Sculean 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 Sep;35(9): jump to Study! jump to Ref! STRAUMANN 65

66 Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bony defects Heden G, Wennström JL J Periodontol Feb;77(2):

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

68 Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects 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 Mean and 95% CI (mm) Clinical stability of intrabony defects treated with Emdogain at 1 and 5 years year 5 years -6.0 Probing depth (PD) Clinical attachment level (CAL) Heden G, Wennström JL STRAUMANN J Periodontol Feb;77(2):

69 Five-year follow-up of regenerative periodontal therapy with enamel matrix derivative at sites with angular bone defects Conclusion The use of Emdogain intrabony defects demonstrated 5-years-stability of clinical attachment level (CAL) gain and probing depth (PD) recession following regenerative therapy Heden G, Wennström JL STRAUMANN J Periodontol Feb;77(2):

70 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 Sep;35(9):

71 Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration Goal To evaluate the 10-year results of intrabony defects treated with: i) Emdogain ii) guided tissue regeneration (GTR) iii) the combination of Emdogain and GTR iv) 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) Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M. STRAUMANN J Clin Periodontol Sep;35(9):

72 Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration Results 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) CAL gain (mean ± SD, mm) Clinical attachment level (CAL) values remain stable up to 10 years after treatment with Emdogain n = 10 n = 9 n = 10 EMD EMD + GTR GTR OFD n = number of patients 1 year 10 years n = 9 Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M. STRAUMANN J Clin Periodontol Sep;35(9):

73 Ten-year results following treatment of intra-bony defects with enamel matrix proteins and guided tissue regeneration Conclusion 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 Sculean A, Kiss A, Miliauskaite A, Schwarz F, Arweiler NB, Hannig M. STRAUMANN J Clin Periodontol Sep;35(9):