title: Clinical safety of enamel matrix derivative (EMDOGAIN) in the treatment of periodontal defects. Enamel matrix derivative (EMDOGAIN) in the treatment of intrabony periodontal defects. Microsurgical access flap in conjunction with enamel matrix derivative for the treatment of intra-bony defects: a controlled clinical trial. Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects: a 24-month multicenter study. Clinical and radiographic effects of enamel matrix derivative in the treatment of intrabony periodontal defects: a 12-month longitudinal placebo-controlled clinical trial in adult periodontitis patients. The efficacy of enamel matrix derivative (Emdogain) for the treatment of deep infrabony periodontal defects: a placebo-controlled randomised clinical trial. Comparison of treatments of infrabony defects with enamel matrix derivative, guided tissue regeneration with a nonresorbable membrane and Widman modified flap. A pilot study. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. Enamel matrix proteins and systemic antibiotics as adjuncts to non-surgical periodontal treatment: clinical effects. 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. Enamel matrix derivative in the treatment of human intrabony osseous defects. Treatment of infrabony defects with or without enamel matrix proteins: a 24-month follow-up randomized pilot study. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. Periodontal regeneration versus extraction and prosthetic replacement of teeth severely compromised by attachment loss to the apex: 5-year results of an ongoing randomized clinical trial. Connective tissue-cementum regeneration: a new histologic regeneration following the use of enamel matrix derivative in dehiscence-type defects. A dog model. Primary flap closure combined with Emdogain alone or Emdogain and Cerasorb in the treatment of intra-bony defects. Healing of human intrabony defects following treatment with enamel matrix proteins or guided tissue regeneration. Assessment of guided tissue regeneration procedures in intrabony defects with bioabsorbable and non-resorbable barriers. Enamel matrix proteins in the regenerative therapy of deep intrabony defects. Enamel matrix proteins in the treatment of intra-bony defects. A prospective 24-month clinical trial. A clinical study evaluating the treatment of supra-alveolar-type defects with access flap surgery with and without an enamel matrix protein derivative: a pilot study. Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: A randomized controlled trial
abstract: 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 consisted of a microsurgical access flap procedure design ed for maximum tissue preservation . The exposed root surfaces of the test sites were conditioned with a 24 % EDTA gel followed by EMD ( Emdogain(R ) ) application . Primary flap closure was achieved by a 2-layered suturing technique . Postoperative healing was evaluated by a newly introduced early wound-healing index ( EHI ) at 1 and 2 weeks after surgery . RESULTS Both test and control treatment result ed in a statistically significant mean CAL gain of 2.8 and 2.0 mm at 6 months , and 3.6 and 1.7 mm at 12 months , respectively ( p<0.05 ) . Differences in CAL gain between the two treatment modalities were statistically significant at both time points ( p<0.05 ) . Additional GR values after 12 months averaged 0.3 and 0.4 mm for test and control sites , respectively , and did not reach statistical significance ( p > or = 0.05 ) . Two weeks after surgery , primary closure was maintained in 89 % of the test sites and in 96 % of the control sites . CONCLUSION Both treatment modalities using the microsurgical flap procedure result ed in a high percentage of primary flap closure and maximum tissue preservation . In terms of PPD reduction and CAL gain , the combination with EMD application appeared to be superior to the microsurgical access flap alone OBJECTIVES The purpose of the present study was to evaluate the clinical effects of non-surgical periodontal treatment , supplemented with enamel matrix derivative ( EMD ) and /or systemic antibiotics , in deep periodontal pockets of patients with chronic periodontitis . METHODS This was a r and omized , placebo-controlled longitudinal clinical trial of 12 months duration . Using a split-mouth design , 16 subjects were r and omly assigned to scaling and root planing ( SRP ) with EMD or placebo in contra-lateral dentition areas . One half of the subjects received 250 mg metronidazole and 375 mg amoxicillin three times a day for 7 days and the other half received a placebo . One inter-proximal periodontal lesion was chosen as study site in each of the contra-lateral quadrants . RESULTS Subjects treated with systemic antibiotics yielded significantly better clinical results than those treated with placebo . In these cases , probing pocket depth was reduced significantly more after 6 months ( 3.0+/-2.1 mm versus 1.6+/-1.4 mm , p=0.05 ) , and the mean clinical attachment gain was significantly greater after 6 months ( 2.3+/-1.9 mm versus 0.7+/-1.6 mm , p=0.02 ) and 12 months ( 2.3+/-3.5 mm versus 0.4+/-3.8 mm , p=0.02 ) . Sites treated with the antibiotics plus EMD gained the largest amount of clinical attachment . There was no significant benefit of EMD adjunctive to SRP in subjects not treated with antibiotics . CONCLUSIONS The present study supports the notion that optimal repair and regeneration of the periodontium requires suppression of the microbiota causing periodontal disease BACKGROUND Previous studies have demonstrated that enamel matrix derivative ( EMD ) has the ability to improve clinical parameters when used to treat intraosseous defects . The purpose of the present study was to compare at 12 months postsurgery sites treated with open flap debridement ( OFD ) alone to those treated with OFD and EMD . METHODS Twenty-three subjects with at least 2 intrabony defects were chosen . Fifty-three defects received EMD in conjunction with OFD .  Thirty-one defects in these same 23 subjects were treated with OFD alone . Stents were fabricated to serve as fixed reference points . Re-entries were performed at least 1 year after initial surgery . Soft tissue measurements were recorded prior to initial surgery and prior to re-entry for gingival ( GI ) and plaque ( PI ) indices , probing depth ( PD ) , gingival margin position , and clinical attachment level ( CAL ) . Hard tissue measurements were recorded during the initial and re-entry surgery for level of crestal bone and depth of defect . Statistical analysis was conducted using the method of generalized estimating equations to determine changes in GI , PI , PD , CAL , fill of the osseous defect , and crestal resorption . Percent of defect fill was also calculated . RESULTS In all categories , treatment with EMD ( test ) was superior to treatment without EMD ( control ) . Average PI and GI were not significantly different either initially or prior to re-entry . The average PD reduction was 2.7 mm greater with EMD than controls . The average CAL gains were 1.5 mm greater , and the average fill of osseous defect 2.4 mm greater with EMD than controls . The average percent of defect fill after adjusting for crestal bone loss was more than 3 times greater for EMD versus control-treated sites ( 74 % defect fill with EMD versus 23 % defect fill for control sites ) . CONCLUSIONS This study indicates that treatment of periodontal intraosseous defects with EMD is clinical ly superior to treatment without EMD ( open flap debridement ) in every parameter evaluated . Re-entry data demonstrate that percent fill of osseous defects treated with EMD compares favorably with the treatment results utilizing bone grafts or membrane barriers , according to published literature BACKGROUND There is limited information available from clinical trials regarding the performance of enamel matrix derivative ( EMD ) in the treatment of periodontal intrabony defects . This r and omized , double-blind , placebo-controlled , split-mouth study was design ed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects . METHODS Sixteen patients were included , each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch . Thirty-six intrabony defects were r and omly assigned treatment with flap surgery plus EMD or flap surgery plus placebo . At baseline and at the 12-month follow-up evaluation visit , clinical and radiographic measurements were determined . Data were statistically analyzed using the Wilcoxon-signed rank test ( alpha = 0.05 ) . RESULTS At the 12-month visit , bleeding on probing for the EMD group was 0.11 + /- 0.32 compared to the placebo group , 0.61 + /- 0.50 ( P < 0.05 ) . Probing depth reduction was greater in the EMD group ( 3.00 + /- 0.97 mm ) compared to the placebo group ( 2.22 + /- 0.81 mm ) ( P < 0.05 ) . Mean values for clinical attachment gain in the EMD and the placebo groups were 1.72 + /- 1.07 mm and 0.83 + /- 0.86 mm , respectively ( P < 0.05 ) . Vertical relative attachment gain was 38.5 + /- 22.6 % in the EMD group and 21.4 + /- 25.2 % in the placebo group ( P<0.05 ) . Radiographic bone density gain was greater in the EMD ( 20.2 + /- 16.6 % ) compared to the placebo group ( -3.94 + /- 23.3 % ) ( P<0.01 ) . CONCLUSIONS Treatment with flap surgery and EMD , compared to flap surgery with placebo , produced a significantly more favorable clinical improvement in intrabony periodontal defects OBJECTIVE To evaluate a comparison of open-flap debridement ( OFD ) with or without the use of enamel matrix proteins ( EMP ) for the treatment of infrabony defects . METHOD AND MATERIAL S Ten volunteers ( 38 infrabony defects ) were r and omized to receive OFD+EMP ( test site ) and OFD ( control site ) . Clinical outcomes included mean changes in Plaque Index , Gingival Index , probing pocket depth ( PPD ) , relative attachment level ( RAL ) , gingival recession , width of keratinized tissue , and dental mobility at baseline and at 24 months . RESULTS A significant reduction of 4.21+/-0.97 mm was observed in PPD for the OFD+EMP group ( from 6.30+/-0.99 mm to 2.09+/-0.97 mm ) and of 3.28+/-1.23 mm for the OFD group ( from 6.13+/-0.88 mm to 2.85+/-1.42 mm ) ( P<.001 ) . The reduction in PPD was statistically significantly greater for OFD+EMP compared to OFD ( P=.03 ) . The mean RAL decreased from 13.26+/-1.88 mm to 7.57+/-2.05 mm for the OFD+EMP group ( a gain of 5.69+/-1.96 mm ) and from 13.37+/-1.71 mm to 8.13+/-1.34 mm ( P<.001 ) for the OFD group ( a gain of 5.24+/-1.55 mm ) . Gingival recession was higher in the OFD+EMP group than in the OFD group . The mean keratinized tissue significantly decreased from 4.41+/-1.39 mm to 3.63+/-1.54 mm for OFD flap group ( P<.01 ) . CONCLUSION Both treatment modalities were efficient in improving RAL and PPD . Within groups , there was a significant reduction in keratinized tissue for OFD and a significant postoperative recession for the OFD + EMP group . Infrabony defects treated with OFD + EMP showed significantly more PPD reduction when compared to OFD AIMS This three-arm study compared the clinical and radiographic efficacy of the modified minimally invasive surgical technique ( M-MIST ) alone and combined with enamel matrix derivative ( EMD ) or EMD plus bone mineral derived xenograph ( BMDX ) , in the treatment of isolated , inter-dental intra-bony defects . MATERIAL S AND METHODS Forty-five deep isolated intra-bony defects in 45 patients were included , accessed with the M-MIST and r and omly assigned to three balanced experimental groups . The M-MIST consisted of a small buccal flap without elevation of the defect-associated papilla . After removal of the granulation tissue by sharp dissection and root instrumentation the regenerative material was applied , when indicated , before obtaining primary closure with a single internal modified mattress suture . Surgery was performed with the aid of an operating microscope and microsurgical instruments . Outcomes were evaluated as pocket depth reduction , attachment level gain , radiographic bone fill and patient-related outcomes . RESULTS Primary wound closure was maintained in all treated sites with the exception of one M-MIST EMD+BMDX site . No patient reported intra-operative or post-operative pain . Within group differences between baseline and 1 year were statistically significant in the three groups in terms of probing pocket depth reduction , clinical attachment level ( CAL ) gain and bone fill ( p<0.0001 ) . Comparisons among the thre groups showed no statistically significant difference in any of the measured clinical outcomes . In particular , CAL gains of 4.1±1.4 mm were observed in the M-MIST control group , 4.1±1.2 mm in the EMD group and 3.7±1.3 mm in the EMD+BMDX one . The percentage radiographic bone fill of the intra-bony component was 77±19 % in the M-MIST control group , 71±18 % in the EMD group and 78±27 % in the EMD+BMDX group . CONCLUSIONS M-MIST with or without regenerative material s result ed in significant clinical and radiographic improvements . While this initial study did not have sufficient power to detect inter-group CAL differences < 0.96 mm , the observed outcomes were remarkably similar and warrant further investigations AIMS Aim of this r and omized , long-term clinical trial was to compare clinical - and patient-based outcomes following periodontal regeneration or extraction and replacement of hopeless teeth with chronic perio-endo lesions and /or attachment loss to or beyond the apex . METHODS Fifty patients presenting with generalized severe periodontitis and at least one hopeless tooth to be extracted for periodontal reasons were entered in this study . The test treatment consisted in the application of a regenerative strategy to 25 hopeless teeth . The control treatment consisted in the extraction of the 25 hopeless teeth and their replacement with conventional or implant-supported fixed partial dentures . RESULTS In the control group , 14 teeth were replaced with implant-supported restorations , eight with tooth-supported bridges , two with Maryl and bridges , while one was not replaced . All fixed partial dentures survived the 5-year follow-up period and 83 % were free from biological complications . In the test group , 23 of the 25 regenerated teeth showed important clinical improvements : the two teeth with unsatisfactory outcomes were extracted at 1 year . The 23 successfully regenerated teeth ( 92 % ) were in good health and function at 5-year examination visit and 84 % did not develop biological complications during the recall period . All patients consistently reported comfort in function at the experimental test and control units . In the test group , average clinical attachment level gains were 7.7±2.8 mm , radiographic bone gain 8.5±3.1 mm , probing pocket depth ( PPD ) reduction 8.8±3 mm . Residual PPDs were 4±1.7 mm . Most of the regenerated teeth showed a decrease in tooth mobility . CONCLUSIONS Regenerative therapy can be applied at hopeless teeth and has the potential to change their prognosis ; it is a suitable alternative to extraction of severely compromised teeth with intra-bony defects to or beyond the root apex The goal of this investigation was to evaluate histologically and histometrically the healing process in dehiscence-type defects treated by enamel matrix derivative ( EMD ) .  Five adult female beagle dogs were used . Buccal osseous dehiscences were surgically created on the maxillary canines and the second and fourth premolars . Thirty defect sites were r and omly assigned to treatment and control groups ( 15 defect sites for each group ) . The treatment group received EMD application , while the control groups received no EMD . After 4 months of healing , the dogs were sacrificed and tissue blocks were prepared . Histometric parameters were employed to evaluate the type of periodontal tissues that formed in the defects . All created dehiscence defects in the test sites treated by EMD had formed functional connective tissue fibers inserted into regenerated cellular cementum . The mean amount of apicocoronal regenerated cementum was 3.74 + /- 0.43 mm in EMD- treated sites , whereas the control sites had not formed cementum in the created dehiscence defects ( P < .000 ) . Statistically significant differences were found between treatment and control sites . Within the limits of this study , it can be concluded that EMD alone effectively promoted new cementum and functionally oriented connective tissue formation OBJECTIVES To compare clinical outcomes of three different modalities of treatment for deep intra-bony defects . MATERIAL AND METHODS Fifty-six patients were paralleled for clinical parameters and r and omly assigned to treatment . They displayed one angular defect each with an intra-bony component > or =3 mm , probing pocket depth ( PPD ) and probing attachment level ( PAL )  > or = 7 mm , and plaque index ( PI ) < 1 . Nineteen defects were treated , respectively , with enamel matrix derivative (EMD)+tricalcium phosphate ( TCP ) or EMD alone and 18 defects with modified Widman flap ( MWF ) . Primary flap closure was used in all three groups . PI , gingival index , bleeding on probing , PPD , PAL , and recession ( REC ) were measured before and 12 months after treatment . RESULTS Treatment with EMD alone yielded a 3.9+/-1.3 mm PPD decrease and a 3.7+/-1.0 mm PAL gain ( p<0.001 ) , whereas EMD+beta-TCP produced a 4.1+/-1.2 mm PPD reduction and a 4.0+/-1.0 mm PAL gain ( p<0.001 ) . These outcome parameters did not differ between the two groups . REC increased by 0.7+/-1.3 mm . After MWF treatment , attachment gain was 2.1+/-1.4 mm ( p<0.001 ) and PPD reduction was 3.8+/-1.8 mm , whereas REC increased by 1.5+/-0.7 mm ( p=0.042 versus EMD ) . CONCLUSION Both EMD treatments showed similar clinical effects , with significant PAL gain and a significantly lower REC increase in comparison with MWF treatment The aim of the present study was to evaluate histologically in humans the healing of advanced intrabony defects following treatment with enamel matrix proteins ( EMD ) or guided tissue regeneration ( GTR ) .  Fourteen patients , each of them displaying 1 advanced intrabony defect around teeth scheduled for extraction were included in the study . The defects were treated r and omly either with an enamel matrix protein derivative ( Emdogain , BIORA AB , Malmö , Sweden ) or with a bioabsorbable membrane ( Resolut , Regenerative Material , W.L. Gore & Assoc . , Flagstaff , Arizona , USA ) . At baseline the mean probing pocket depth ( PPD ) in the EMD group was 11.3 + /- 1.8 mm and the mean clinical attachment level ( CAL ) 12.1 + /- 2.0 mm , whereas in the GTR group the mean PPD was 11.4 + /- 2.2 mm and the mean CAL 13.3 + /- 2.3 mm . Healing was uneventful in all cases . Neither allergic reactions against EMD or the bioabsorbable membrane , nor suppuration or abscesses were observed . The clinical results revealed at 6 months in the EMD group a mean PPD of 5.6 + /- 1.3 mm and a mean CAL of 9.1 + /- 1.5 mm . In the GTR group the mean PPD was 5.6 + /- 1.3 mm and the mean CAL 10.1 + /- 1.5 mm . The histological analysis showed in the EMD group a mean 2.6 + /- 1.0 mm of new attachment ( i.e. new cementum with inserting collagen fibers ) and a mean 0.9 + /- 1.0 mm of new bone . In this group , the formation of new attachment was not always followed by bone regeneration . In the GTR group , the mean new attachment was 2.4 + /- 1.0 mm and the mean new bone 2.1 + /- 1.0 mm . In every case treated with GTR , the formation of new attachment was followed by a varying amount of new bone . After both types of regenerative treatment the newly formed cementum displayed a predominantly cellular character . The findings of the present study indicate that the treatment of intrabony defects with enamel matrix proteins or with bioabsorbable membranes enhances the formation of a new connective tissue attachment in humans THE PURPOSE OF THIS STUDY was to assess periodontal regenerative techniques in intrabony defects utilizing a bioabsorbable , polylactic acid ( PLA ) barrier or the non-resorbable , exp and ed polytetrafluoroethylene ( ePTFE ) barrier .  Thirty patients ( 26 to 64 years old ) each with one radiographically evident intrabony periodontal lesion of probing depth > or = 6 mm participated in a 12-month controlled clinical trial . The subjects were r and omly divided into two independent groups . The test group ( n = 16 ) received a PLA barrier . The control group ( n = 14 ) received an ePTFE barrier .  Plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , clinical attachment level ( CAL ) , and bone fill were recorded by a single calibrated examiner not involved with the surgical treatment prior to surgery , and at 6 , 9 , and 12 months postsurgery . The treatment results were statistically analyzed utilizing two sets of data . The " averaged-site " data set consisted of values computed from the averaging of measurements from all sites encompassing the defect . The second data set was comprised of only the deepest measurement of the defect . Statistical tests used to analyze these data sets included the t-test and paired t-test for parametric data and the Wilcoxon rank sum test and the Wilcoxon signed rank test for non-parametric data . Analyses with both the averaged-site data and deepest-site data result ed in significant improvements in PD reductions , CAL , and bone fill , after 12 months of healing with both the PLA and ePTFE barrier devices . Comparisons of healing response between treatments found no significant differences when the averaged-site data were analyzed . When only the deepest site of the defect was considered , the control group result ed in significantly more attachment gain ( ePTFE , 3.36 mm ; PLA , 1.75 mm ; P < 0.02 ) and shallower probing depths ( ePTFE , 3.29 mm ; PLA , 4.69 mm ; P < 0.01 ) than the test group . In intrabony defects , the use of PLA or ePTFE barriers in GTR procedures yielded comparable clinical results ; however , in this study , data analysis using the deepest site of the defect found , after 12 months of healing , significantly more attachment gain and shallower probing depths with ePTFE AIM This prospect i ve multicentre r and omized controlled clinical trial was design ed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of enamel matrix proteins ( EMD ) . MATERIAL AND METHODS 172 patients with advanced chronic periodontitis were recruited in 12 centers in 7 countries . All patients had at least one intrabony defect of > or = 3 mm . Heavy smokers ( > or = 20 cigarettes/day ) were excluded . The surgical procedures included access for root instrumentation using either the simplified or the modified papilla preservation flap in order to obtain optimal tissue adaptation and primary closure . After debridement , roots were conditioned for 2 min with a gel containing 24 % EDTA . EMD was applied in the test subjects , and omitted in the controls . Postsurgically , a strict plaque control protocol was followed . At baseline and 1 year following the interventions , clinical attachment levels ( CAL ) , pocket probing depths ( PPD ) , recession ( REC ) , full-mouth plaque scores and full-mouth bleeding scores were assessed . A total of 166 patients were available for the 1-year follow-up . RESULTS At baseline , 86 test and 86 control patients presented with similar subject and defect characteristics . On average , the test defects gained 3.1+/-1.5 mm of CAL , while the control defects yielded a significantly lower CAL gain of 2.5+/-1.5 mm . Pocket reduction was also significantly higher in the test group ( 3.9+/-1.7 mm ) when compared to the controls ( 3.3+/-1.7 mm ) . A multivariate analysis indicated that the treatment , the clinical centers , cigarette smoking , baseline PPD , and defect corticalisation significantly influenced CAL gains . A frequency distribution analysis of the studied outcomes indicated that EMD increased the predictability of clinical ly significant results ( CAL gains > or = 4 mm ) and decreased the probability of obtaining negligible or no gains in CAL ( CAL gains < 2 mm ) . CONCLUSIONS The results of this trial indicated that regenerative periodontal surgery with EMD offers an additional benefit in terms of CAL gains , PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone BACKGROUND A growing flow of recent evidence indicates enamel matrix derivative ( EMD , Emdogain ) as a useful tool for the regeneration of periodontal tissues . This prospect i ve clinical study aim ed to evaluate the efficacy of EMD combined with surgical treatment of periodontal intra-bony defects , as compared with surgery alone , up to 24 months of follow-up . METHODS Twenty-four intra-bony defects were treated in 24 patients in a single clinical centre . Each defect had intra-bony depth ( IBD ) > or = 4 mm and probing pocket depth ( PPD ) > or = 6 mm . Patients were r and omly assigned to either test or control group . Plaque index ( PI ) , gingival index ( GI ) , PPD and periodontal attachment level ( PAL ) were assessed at baseline pre-surgical examination at the site to be treated . Full mouth plaque score ( FMPS ) and full mouth bleeding score ( FMBS ) were also evaluated . Twelve patients were treated by simplified papilla preservation flap technique ( control group ) , while 12 patients were treated with the same surgical technique plus EMD after ethylenediamine tetraacetic acid root conditioning ( test group ) . Any probing at the involved sites was avoided in the first year post-surgery . Radiographs were taken at baseline , 12 and 24 months after surgery using customized bite blocks . Intra-bony defect depth ( IBD ) and angle ( IBA ) were measured from X-rays by a computer-aided technique . At 12 and 24 months post-surgery , FMPS , FMBS , PI , GI , PPD , PAL and radiographic IBD and IBA were assessed . The difference between each follow-up and baseline , and between groups at each follow-up was evaluated for the above parameters by st and ard statistical methods . RESULTS In both groups , clinical and radiographic parameters were improved at either 12 or 24 months when compared with baseline . The test group displayed better outcomes when compared with the control group for IBD , PPD , and PAL gain at 12 months , and only for PAL and IBD gain at 24 months . No adverse event related to the use of EMD was reported . CONCLUSIONS The surgical procedure used in the present study , aim ing for maximum preservation of the regenerative potential of periodontal tissues , showed per se excellent results . The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects possibly enhances periodontal regeneration rate AIM There is evidence that regenerative treatment of intra-bony and m and ibular class II furcation defects with access flap and an application of an enamel matrix protein derivative ( EMD ) can result in a clinical benefit compared with access flap alone . The aim of this pilot study was to check if the results of access flap surgery in suprabony defects are improved by additional application of EMD . MATERIAL AND METHODS Thirty-nine adult subjects with supra-alveolar-type defects were r and omly assigned to a test ( n=25 ) and a control group ( n=14 ) . Seventy teeth were treated with EMD ; 28 teeth were treated by access flap .  Probing depth ( PD ) , clinical attachment level and bleeding on probing were evaluated at baseline and after 12 months . RESULTS PD of the operated teeth was improved in both groups ( p<0.001 to p=0.041 ) but always better in the test group . The attachment gain was 2.72+/-1.80 mm at sites with an initial PD > or=7 mm in the test group and 0.78+/-0.62 mm in the control group ( p=0.004 ) . In the test group the mean attachment gain was 0.97+/-0.92 mm ( p<0.001 ) ; the mean reduction of PD was 1.55+/-0.90 mm ( p<0.001 ) . CONCLUSIONS The data suggest a significant clinical benefit of supplementary application of EMD during surgical treatment of periodontitis of supra-alveolar pockets , especially in deeper pockets Abstract Introduction . Emdogain ® represents an extracellular matrix derivative that controls and promotes periodontal regeneration . Several studies have demonstrated that the treatment of periodontal defects with Emdogain ® leads to improvements in clinical parameters . However , long-time clinical trials establishing clinical usefulness of Emdogain ® are scarce . Therefore , the present r and omized split mouth , controlled study was undertaken to evaluate the effectiveness of Emdogain ® as an adjunct to open flap debridement for the treatment of intra-bony defects over a period of 5 years . Material s and methods . The study population consisted of 15 chronic periodontitis patients with bilateral interproximal osseous defects . The test group was treated by open flap debridement with EDTA 24 % ( PrefGel ® ) followed by enamel matrix derivative ( Emdogain ® ) . The control group was treated by open flap debridement with EDTA 24 % ( PrefGel ® ) . Results . After 1 and 5 years , both the test and control groups showed significant mean PPD reduction . A greater reduction in mean Probing Pocket Depth ( PPD ) was observed in the test group ( 3.84 ± 1.05 ) as compared to the control group ( 1.92 ± 0.35 ) . The mean Clinical Attachment Level ( CAL ) gain of 3.18 ± 0.87 mm was observed in the test group , while the control group displayed mean CAL gain of 1.60 ± 0.54 mm . The observed differences were found to be statistically significant in both the groups ( p < 0.05 ) . Percentage bone fill was significantly increased at 12 months post-surgery in test group ( 66.66 ± 7.8 % ) as compared to control group ( 31.71 ± 4.1 % ) . Conclusion . The treatment with Emdogain result ed in a significantly higher CAL gain and PPD reduction in comparison with OFD and PrefGel ®
target: In conclusion , follow-up time ( < or > 2 years ) and the risk of bias influence the results of treatment with EMDP in IPD
background: Previous systematic review s have demonstrated better results with enamel matrix derivative proteins ( EMDP ) as compared with open flap debridement ( OFD ) for the management of infrabony periodontal defects ( IPD ) .
  The aim of this study was to determine whether these differences vary according to the follow-up and quality of the studies .