human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN in a large number of patients . An open , controlled study design in 10 Swedish specialist clinics was chosen , with a test group of 107 patients treated with EMDOGAIN in connection with periodontal surgery at 2 surgical test sites per patient . The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions . A control group of 33 patients underwent flap surgery without EMDOGAIN at 1 comparable site . In total , 214 test and 33 control surgeries were performed .  Serum sample s were obtained from test patients for analysis of total and specific antibody levels .  10 of the patients had sample s taken before and after the first surgery , 56 other sample s were taken after one treatment with EMDOGAIN , and 63 after 2 treatments . None of the sample s , not even from allergy-prone patients after 2 treatments , indicated deviations from established baseline ranges . This indicates that the immunogenic potential of EMDOGAIN is extremely low when applied in conjunction with periodontal surgery . Comparison between the test and control groups demonstrated the same type and frequency of postsurgical experiences , i.e. , reactions caused by the surgical procedure itself . Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery . About half of the patients ( 44 test and 21 control ) were also evaluated after 3 years . There was a significant difference between the test and control results at 8 months postsurgery , and this difference had increased further at the 3 year follow-up . The 2.5 - 3 mm increase in attachment and bone level after treatment with EMDOGAIN was of the same magnitude as seen in the studies with split-mouth design aim ing for test of effectiveness of EMDOGAIN The aim of the present clinical trial was to compare the long-term effect of EMDOGAIN treatment as an adjunct to modified widman flap ( MWF ) surgery with the effect of MWF and placebo treatment . The investigation was a placebo-controlled , r and omized multicenter trial involving 33 subjects with 34 paired test and control sites . The protocol required 2 interproximal sites , appropriately separated , in the same jaw with probing pocket depths > or = 6 mm and an associated intrabony defect with a depth of > or = 4 mm and a width of > or = 2 mm as measured on a radiograph . Only predominantly 1- and 2-wall defects were included .  Clinical attachment gain and radiographic bone gain were used as primary outcome variables . Assessment s were made at baseline , 8 , 16 and 36 months . Mean values for clinical attachment level gain in test and control sites at 8 months were 2.1 mm and 1.5 mm , respectively ; at 16 months , 2.3 mm and 1.7 mm , respectively ; and at 36 months 2.2 mm and 1.7 mm , respectively ; and the differences were statistically significantly different at each time point ( p < 0.01 ) . The radiographic bone level continued to increase over the 36 months at the EMDOGAIN-treated sites , while it remained close to the baseline level at the control sites . The statistically significant ( p < 0.001 ) radiographic bone gain at 36 months of 2.6 mm at EMDOGAIN-treated sites corresponded to 36 % gain of initial bone loss or 66 % defect fill . The present trial has demonstrated that topical application of EMDOGAIN onto diseased root surfaces associated with intrabony defects during MWF periodontal surgery will promote an increased gain of radiographic bone and clinical attachment compared to control ( placebo application ) surgery in the same patient . There was no evidence to indicate any clinical adverse effects from application of EMDOGAIN conjunction with periodontal surgery OBJECTIVES The aims of this controlled study were to clinical ly and radiographically evaluate the effect of a microsurgical approach for the treatment of intra-bony defects with and without an enamel matrix derivative ( EMD ) . Parts of this study population were already published by Wachtel and colleagues in 2003 . MATERIAL AND METHODS Seventy intra-bony defects were r and omly assigned to a microsurgical access flap with application of EMD ( test group ) and on the contra-lateral side to a microsurgical access flap alone ( control group ) . Clinical and radiographic parameters were assessed at baseline and after 6 and 12 months . RESULTS Both test and control treatments result ed in a statistically significant mean clinical attachment level ( CAL ) gain , probing pocket depth ( PPD ) reduction and radiographic bone fill . The test group yielded statistically significantly more CAL gain , PPD reduction and radiographic bone fill than the control group . Gingival recession increase after 12 months averaged 0.5 and 0.7 mm for the test and control groups , and did not reach statistical significance . Two weeks after surgery , primary wound closure was maintained in 91 % of the test sites and 97 % of the control sites . CONCLUSION The combination of a microsurgical access flap with EMD seems to be superior to open flap debridement in terms of PPD reduction , CAL gain and radiographic bone fill . In the test as well as the control group , primary wound closure was successfully achieved The aim of this prospect i ve multicenter controlled clinical study was to evaluate the efficacy of Emdogain ( Biora ) , an enamel matrix derivative ( EMD ) , when combined with surgical treatment of periodontal angular defects , as compared to surgery alone , for up to 24 months of follow-up . The study was performed at six Italian universities and 11 private practice s. Patients with one- , two- , or three-wall angular defects were enrolled if intrabony defect depth ( IBD ) was 4 mm or more and probing pocket depth ( PPD ) was at least 6 mm . They were r and omly allocated to either test or control groups . The test group was treated by the simplified papilla preservation ( SPP ) flap plus Emdogain after root conditioning with ethylenediaminetetraacetic acid . The control group was treated by SPP alone .  Plaque Index , Gingival Index , PPD , and periodontal attachment level ( PAL ) at surgical sites were assessed at the presurgical examination ( baseline ) . IBD was measured intraoperatively after debridement . IBD was also evaluated with a computer-aided technique , from periapical radiographs . Plaque Index , Gingival Index , PPD , PAL , and IBD were assessed at 12 and 24 months postsurgery . Data were further divided in two subgroups according to baseline IBD ( 6 mm or less and more than 6 mm ) . The differences between each follow-up and baseline , and between groups at each follow-up , for the above parameters were evaluated by st and ard statistical methods . One hundred fifty-three patients were recruited , accounting for 195 intrabony defects : 83 patients ( 108 defects ) and 70 patients ( 87 defects ) were allocated to the test and control groups , respectively . All parameters were improved at both 12 and 24 months , compared to baseline in both groups . In the test group , IBD , PPD , and PAL at 12 months were significantly better than these parameters in the control group . The test subgroup with IBD of more than 6 mm at baseline displayed a better outcome when compared to the 6 mm or less IBD subgroup . No significant adverse events related to the use of Emdogain were reported . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects significantly enhanced the rate and degree of periodontal regeneration . The control group also displayed significant tissue regeneration , but at a slower rate compared to the Emdogain group . The surgical procedure itself , with its goal of maximum preservation of the regenerative potential of periodontal tissues , proved to be effective in the treatment of periodontal angular defects . Pockets with IBD greater than 6 mm showed major improvement when treated with Emdogain BACKGROUND This r and omized , double-masked , placebo-controlled clinical trial evaluated the effect of enamel matrix derivative ( EMD ) on clinical and radiographic parameters of periodontal intrabony defects . METHODS A split-mouth design was used in 16 chronic periodontitis patients who had similar defects ( > or = 6 mm of probing depth ) . Both groups underwent scaling and root planing and were acid-etched with EDTA . The test sites received the EMD solution and the controls a placebo . Clinical examinations of all 16 patients and radiographs of 14 patients were available at baseline and 6 and 12 months after surgery . Clinical outcomes included probing depth ( PD ) and clinical attachment level ( CAL ) ; radiographic analysis was performed using computerized linear measurements . Intergroup comparisons were performed by paired sample s t test , and over time comparisons were made by general linear model ( alpha = 0.05 ) . RESULTS A statistically significant improvement over time for PD and CAL and a decrease of the vertical component of the defect was detected in both groups . Comparisons between groups revealed at baseline a mean+/-SD value of CAL of 12.93+/-2.00 and 13.47+/-2.93 for test and control groups , respectively . These values decreased to 10.92+/-1.92 and 11.31+/-1.86 after 12 months for test and control . No statistically significant differences could be observed between groups . PD displayed similar results from 7.57+/-1.02 and 7.38+/-1.16 for test and control groups at baseline to 3.40+/-1.82 and 2.99+/-1.07 after 12 months . If the data are divided into smokers and non-smokers , no differences are observed . CONCLUSION Use of EMD did not result in more improvement in clinical and radiographic parameters compared to the placebo PURPOSE To evaluate the efficacy of Emdogain versus placebo ( its carrier ) for the treatment of deep infrabony defects . MATERIAL S AND METHODS Thirty patients with an infrabony defect of at least 4 mm deep and at least 2 mm wide were r and omly allocated for treatment with either Emdogain or placebo ( the Emdogain carrier ) . The treating clinician was completely blinded to the therapy provided and performed all evaluations blindly up to the third year of follow-up . Outcome measures were tooth loss , complications , post-operative healing , patient 's satisfaction with treatment and aesthetics , changes in probing attachment levels ( PAL ) , probing pocket depths ( PPD ) , gingival recessions ( REC ) and radiographic bone levels ( RAD ) . RESULTS One year after treatment , both therapies had significantly improved clinical outcome measures : placebo group PAL gain = 3.3 mm , PPD reduction = 3.9 mm , and RAD gain = 2.5 mm ; Emdogain group PAL gain = 3.4 mm , PPD reduction = 4.2 mm , and RAD gain = 2.5 mm . Both therapies induced statistically significant gingival recession ( 0.6 mm in the placebo and 0.8 mm in the Emdogain group ) . There were no statistically significant differences between groups for any of the outcomes tested . No teeth had to be extracted up to 3 years after treatment . CONCLUSIONS There does not appear to be any clinical advantage when using Emdogain over its carrier ( placebo ) in the treatment of deep and wide infrabony defects BACKGROUND , AIMS The purpose of the present study was to compare the efficacy of 3 different surgical procedures in the treatment of infrabony defects :  guided tissue regeneration ( GTR ) with non-resorbable membranes , Widman modified flap ( WMF ) and enamel matrix derivative ( EMD ) . METHOD 30 patients with an infrabony component > or = 4 mm were selected . 10 were treated with exp and ed polytetrafluorethylene ( ePTFE ( Gore - Tex W. L. Gore and Associates , Flagstaff , AZ , USA ) ) membranes , 10 with WMF and 10 with enamel matrix derivatives ( Emdogain ( U Biora AB Malm , Sweden ) ) . The efficacy of each treatment modality was investigated through regression analysis . Probing attachment level ( PAL ) gain , probing depth ( PD ) reduction and gingival recession ( REC ) variation were analyzed . RESULTS Both Emdogain ( enamel matrix derivative ) and ePTFE treatment show significant better results as compared to the WMF procedure in which there were no significant changes in PAL gain and PD reduction at baseline and 1 year after surgery . CONCLUSIONS Results from our analysis suggest that there is no statistically significant difference in PAL gain between GTR and EMD . The clinical outcomes of this pilot study may be of little significance , considering the small number of patients , but it has provided an important base for a controlled clinical trial ( with a larger number of patients ) which is currently in progress OBJECTIVES Application of the guided tissue regeneration ( GTR ) principle and utilization of enamel matrix derivative ( EMD ) have both been shown to result in periodontal regeneration . While clinical investigations have demonstrated that the use of a microsurgical concept in combination with the GTR technique positively affects the percentage of primary closure and the amount of tissue preservation , no such information is available for EMD-treated periodontal defects . It was the aim of the present investigation to assess the clinical effect of the microsurgical access flap and EMD treatment with an emphasis on the evaluation of early wound healing . MATERIAL AND METHODS Eleven patients displaying at least one pair of intrabony periodontal defects with an intrabony component of > or =3 mm participated in the study . At baseline and at 6 and 12 months after surgery , the following clinical parameters were assessed by a blinded examiner : oral hygiene status ( API ) , gingival inflammation ( BOP ) , probing pocket depth ( PPD ) , clinical attachment level ( CAL ) and gingival recession ( GR ) . Defects were r and omly assigned to test or control treatment , which both 
    Output:
    
agent
In conclusion , follow-up time ( < or > 2 years ) and the risk of bias influence the results of treatment with EMDP in IPD
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN in a large number of patients . An open , controlled study design in 10 Swedish specialist clinics was chosen , with a test group of 107 patients treated with EMDOGAIN in connection with periodontal surgery at 2 surgical test sites per patient . The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions . A control group of 33 patients underwent flap surgery without EMDOGAIN at 1 comparable site . In total , 214 test and 33 control surgeries were performed .  Serum sample s were obtained from test patients for analysis of total and specific antibody levels .  10 of the patients had sample s taken before and after the first surgery , 56 other sample s were taken after one treatment with EMDOGAIN , and 63 after 2 treatments . None of the sample s , not even from allergy-prone patients after 2 treatments , indicated deviations from established baseline ranges . This indicates that the immunogenic potential of EMDOGAIN is extremely low when applied in conjunction with periodontal surgery . Comparison between the test and control groups demonstrated the same type and frequency of postsurgical experiences , i.e. , reactions caused by the surgical procedure itself . Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery . About half of the patients ( 44 test and 21 control ) were also evaluated after 3 years . There was a significant difference between the test and control results at 8 months postsurgery , and this difference had increased further at the 3 year follow-up . The 2.5 - 3 mm increase in attachment and bone level after treatment with EMDOGAIN was of the same magnitude as seen in the studies with split-mouth design aim ing for test of effectiveness of EMDOGAIN The aim of the present clinical trial was to compare the long-term effect of EMDOGAIN treatment as an adjunct to modified widman flap ( MWF ) surgery with the effect of MWF and placebo treatment . The investigation was a placebo-controlled , r and omized multicenter trial involving 33 subjects with 34 paired test and control sites . The protocol required 2 interproximal sites , appropriately separated , in the same jaw with probing pocket depths > or = 6 mm and an associated intrabony defect with a depth of > or = 4 mm and a width of > or = 2 mm as measured on a radiograph . Only predominantly 1- and 2-wall defects were included .  Clinical attachment gain and radiographic bone gain were used as primary outcome variables . Assessment s were made at baseline , 8 , 16 and 36 months . Mean values for clinical attachment level gain in test and control sites at 8 months were 2.1 mm and 1.5 mm , respectively ; at 16 months , 2.3 mm and 1.7 mm , respectively ; and at 36 months 2.2 mm and 1.7 mm , respectively ; and the differences were statistically significantly different at each time point ( p < 0.01 ) . The radiographic bone level continued to increase over the 36 months at the EMDOGAIN-treated sites , while it remained close to the baseline level at the control sites . The statistically significant ( p < 0.001 ) radiographic bone gain at 36 months of 2.6 mm at EMDOGAIN-treated sites corresponded to 36 % gain of initial bone loss or 66 % defect fill . The present trial has demonstrated that topical application of EMDOGAIN onto diseased root surfaces associated with intrabony defects during MWF periodontal surgery will promote an increased gain of radiographic bone and clinical attachment compared to control ( placebo application ) surgery in the same patient . There was no evidence to indicate any clinical adverse effects from application of EMDOGAIN conjunction with periodontal surgery OBJECTIVES The aims of this controlled study were to clinical ly and radiographically evaluate the effect of a microsurgical approach for the treatment of intra-bony defects with and without an enamel matrix derivative ( EMD ) . Parts of this study population were already published by Wachtel and colleagues in 2003 . MATERIAL AND METHODS Seventy intra-bony defects were r and omly assigned to a microsurgical access flap with application of EMD ( test group ) and on the contra-lateral side to a microsurgical access flap alone ( control group ) . Clinical and radiographic parameters were assessed at baseline and after 6 and 12 months . RESULTS Both test and control treatments result ed in a statistically significant mean clinical attachment level ( CAL ) gain , probing pocket depth ( PPD ) reduction and radiographic bone fill . The test group yielded statistically significantly more CAL gain , PPD reduction and radiographic bone fill than the control group . Gingival recession increase after 12 months averaged 0.5 and 0.7 mm for the test and control groups , and did not reach statistical significance . Two weeks after surgery , primary wound closure was maintained in 91 % of the test sites and 97 % of the control sites . CONCLUSION The combination of a microsurgical access flap with EMD seems to be superior to open flap debridement in terms of PPD reduction , CAL gain and radiographic bone fill . In the test as well as the control group , primary wound closure was successfully achieved The aim of this prospect i ve multicenter controlled clinical study was to evaluate the efficacy of Emdogain ( Biora ) , an enamel matrix derivative ( EMD ) , when combined with surgical treatment of periodontal angular defects , as compared to surgery alone , for up to 24 months of follow-up . The study was performed at six Italian universities and 11 private practice s. Patients with one- , two- , or three-wall angular defects were enrolled if intrabony defect depth ( IBD ) was 4 mm or more and probing pocket depth ( PPD ) was at least 6 mm . They were r and omly allocated to either test or control groups . The test group was treated by the simplified papilla preservation ( SPP ) flap plus Emdogain after root conditioning with ethylenediaminetetraacetic acid . The control group was treated by SPP alone .  Plaque Index , Gingival Index , PPD , and periodontal attachment level ( PAL ) at surgical sites were assessed at the presurgical examination ( baseline ) . IBD was measured intraoperatively after debridement . IBD was also evaluated with a computer-aided technique , from periapical radiographs . Plaque Index , Gingival Index , PPD , PAL , and IBD were assessed at 12 and 24 months postsurgery . Data were further divided in two subgroups according to baseline IBD ( 6 mm or less and more than 6 mm ) . The differences between each follow-up and baseline , and between groups at each follow-up , for the above parameters were evaluated by st and ard statistical methods . One hundred fifty-three patients were recruited , accounting for 195 intrabony defects : 83 patients ( 108 defects ) and 70 patients ( 87 defects ) were allocated to the test and control groups , respectively . All parameters were improved at both 12 and 24 months , compared to baseline in both groups . In the test group , IBD , PPD , and PAL at 12 months were significantly better than these parameters in the control group . The test subgroup with IBD of more than 6 mm at baseline displayed a better outcome when compared to the 6 mm or less IBD subgroup . No significant adverse events related to the use of Emdogain were reported . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects significantly enhanced the rate and degree of periodontal regeneration . The control group also displayed significant tissue regeneration , but at a slower rate compared to the Emdogain group . The surgical procedure itself , with its goal of maximum preservation of the regenerative potential of periodontal tissues , proved to be effective in the treatment of periodontal angular defects . Pockets with IBD greater than 6 mm showed major improvement when treated with Emdogain BACKGROUND This r and omized , double-masked , placebo-controlled clinical trial evaluated the effect of enamel matrix derivative ( EMD ) on clinical and radiographic parameters of periodontal intrabony defects . METHODS A split-mouth design was used in 16 chronic periodontitis patients who had similar defects ( > or = 6 mm of probing depth ) . Both groups underwent scaling and root planing and were acid-etched with EDTA . The test sites received the EMD solution and the controls a placebo . Clinical examinations of all 16 patients and radiographs of 14 patients were available at baseline and 6 and 12 months after surgery . Clinical outcomes included probing depth ( PD ) and clinical attachment level ( CAL ) ; radiographic analysis was performed using computerized linear measurements . Intergroup comparisons were performed by paired sample s t test , and over time comparisons were made by general linear model ( alpha = 0.05 ) . RESULTS A statistically significant improvement over time for PD and CAL and a decrease of the vertical component of the defect was detected in both groups . Comparisons between groups revealed at baseline a mean+/-SD value of CAL of 12.93+/-2.00 and 13.47+/-2.93 for test and control groups , respectively . These values decreased to 10.92+/-1.92 and 11.31+/-1.86 after 12 months for test and control . No statistically significant differences could be observed between groups . PD displayed similar results from 7.57+/-1.02 and 7.38+/-1.16 for test and control groups at baseline to 3.40+/-1.82 and 2.99+/-1.07 after 12 months . If the data are divided into smokers and non-smokers , no differences are observed . CONCLUSION Use of EMD did not result in more improvement in clinical and radiographic parameters compared to the placebo PURPOSE To evaluate the efficacy of Emdogain versus placebo ( its carrier ) for the treatment of deep infrabony defects . MATERIAL S AND METHODS Thirty patients with an infrabony defect of at least 4 mm deep and at least 2 mm wide were r and omly allocated for treatment with either Emdogain or placebo ( the Emdogain carrier ) . The treating clinician was completely blinded to the therapy provided and performed all evaluations blindly up to the third year of follow-up . Outcome measures were tooth loss , complications , post-operative healing , patient 's satisfaction with treatment and aesthetics , changes in probing attachment levels ( PAL ) , probing pocket depths ( PPD ) , gingival recessions ( REC ) and radiographic bone levels ( RAD ) . RESULTS One year after treatment , both therapies had significantly improved clinical outcome measures : placebo group PAL gain = 3.3 mm , PPD reduction = 3.9 mm , and RAD gain = 2.5 mm ; Emdogain group PAL gain = 3.4 mm , PPD reduction = 4.2 mm , and RAD gain = 2.5 mm . Both therapies induced statistically significant gingival recession ( 0.6 mm in the placebo and 0.8 mm in the Emdogain group ) . There were no statistically significant differences between groups for any of the outcomes tested . No teeth had to be extracted up to 3 years after treatment . CONCLUSIONS There does not appear to be any clinical advantage when using Emdogain over its carrier ( placebo ) in the treatment of deep and wide infrabony defects BACKGROUND , AIMS The purpose of the present study was to compare the efficacy of 3 different surgical procedures in the treatment of infrabony defects :  guided tissue regeneration ( GTR ) with non-resorbable membranes , Widman modified flap ( WMF ) and enamel matrix derivative ( EMD ) . METHOD 30 patients with an infrabony component > or = 4 mm were selected . 10 were treated with exp and ed polytetrafluorethylene ( ePTFE ( Gore - Tex W. L. Gore and Associates , Flagstaff , AZ , USA ) ) membranes , 10 with WMF and 10 with enamel matrix derivatives ( Emdogain ( U Biora AB Malm , Sweden ) ) . The efficacy of each treatment modality was investigated through regression analysis . Probing attachment level ( PAL ) gain , probing depth ( PD ) reduction and gingival recession ( REC ) variation were analyzed . RESULTS Both Emdogain ( enamel matrix derivative ) and ePTFE treatment show significant better results as compared to the WMF procedure in which there were no significant changes in PAL gain and PD reduction at baseline and 1 year after surgery . CONCLUSIONS Results from our analysis suggest that there is no statistically significant difference in PAL gain between GTR and EMD . The clinical outcomes of this pilot study may be of little significance , considering the small number of patients , but it has provided an important base for a controlled clinical trial ( with a larger number of patients ) which is currently in progress OBJECTIVES Application of the guided tissue regeneration ( GTR ) principle and utilization of enamel matrix derivative ( EMD ) have both been shown to result in periodontal regeneration . While clinical investigations have demonstrated that the use of a microsurgical concept in combination with the GTR technique positively affects the percentage of primary closure and the amount of tissue preservation , no such information is available for EMD-treated periodontal defects . It was the aim of the present investigation to assess the clinical effect of the microsurgical access flap and EMD treatment with an emphasis on the evaluation of early wound healing . MATERIAL AND METHODS Eleven patients displaying at least one pair of intrabony periodontal defects with an intrabony component of > or =3 mm participated in the study . At baseline and at 6 and 12 months after surgery , the following clinical parameters were assessed by a blinded examiner : oral hygiene status ( API ) , gingival inflammation ( BOP ) , probing pocket depth ( PPD ) , clinical attachment level ( CAL ) and gingival recession ( GR ) . Defects were r and omly assigned to test or control treatment , which both 
    Output:
    