ENAMEL MATRIX DERIVATIVE (EMDOGAIN(R)) IN THE TREATMENT OF INTRABONY PERIODONTAL DEFECTS

The aim of the present clinical trial was to compare the long-term eff ect of EMDOGAIN(R) treatment as an adjunct to modified widman flap (MW F) surgery with the effect of MWF and placebo treatment. The investiga tion was a placebo-controlled, randomized multicenter trial involving 33 subjects with 34 paired test and control sites. The protocol requir ed 2 interproximal sites, appropriately separated, in the same jaw wit h probing pocket depths greater than or equal to 6 mm and an associate d intrabony defect with a depth of greater than or equal to 4 mm and a width of greater than or equal to 2 mm as measured on a radiograph. O nly predominantly 1- and 2-wall defects were included, Clinical attach ment gain and radiographic bone gain were used as primary outcome vari ables. Assessments were made at baseline, 8, 16 and 36 months. Mean va lues 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, respectivel y; and the differences were statistically significantly different at e ach time point (p<0.01). The radiographic bone level continued to incr ease over the 36 months at the EMDOGAIN(R)-treated sites, while it rem ained close to the baseline level al the control sites. The statistica lly significant (p<0.001) radiographic bone gain at 36 months of 2.6 m m at EMDOGAIN(R)-treated sites corresponded to 36% gain of initial bon e loss or 66% defect fill. The present trial has demonstrated that top ical application of EMDOGAIN onto diseased root surfaces associated wi th intrabony defects during MWF periodontal surgery will promote an in creased gain of radiographic bone and clinical attachment compared to control (placebo application) surgery in the same patient, There was n o evidence to indicate any clinical adverse effects from application o f EMDOGAIN(R) conjunction with periodontal surgery.