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, randomized 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. Assessments 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.

There is increasing evidence that cells of the epithelial root sheath synthesize enamel matrix proteins and that these proteins play a fundamental role in the formation of acellular cementum, the key tissue in the development of a functional periodontium. The purpose of the present study was to explore the effect of locally applied enamel matrix and different protein fractions of the matrix on periodontal regeneration in a buccal dehiscence model in monkeys. Buccal, mucoperiosteal flaps were raised from the canine to the 1st molar on each side of the maxilla. The buccal alveolar bone plate, the exposed periodontal ligament and cementum were removed. Various preparations of porcine enamel matrix with or without vehicles were applied before the flaps were repositioned and sutured. After 8 weeks, the healing was evaluated in the light microscope, and morphometric comparisons were made. Application of homogenized enamel matrix or an acidic extract of the matrix containing the hydrophobic, low molecular weight proteins, amelogenins, resulted in an almost complete regeneration of acellular cementum, firmly attached to the dentin and with collagenous fibers extending over to newly formed alveolar bone. After application of fractions obtained by neutral EDTA extraction containing the acidic, high molecular weight proteins of the enamel matrix, very little new cementum was formed and hardly any new bone. The results of the controls in which no test substance was applied before the repositioning of the flap, were very similar to those obtained with the EDTA extracted material. Propylene glycol alginate (PGA), hydroxyethyl cellulose and dextran were tried as vehicles for the enamel matrix preparations. Only PGA in combination with the amelogenin fraction resulted in significant regeneration of the periodontal tissues.

A clinical trial was undertaken to study the effect of one surgical and one non‐surgical treatment modality in patients with advanced periodontal disease. Fifteen patients were selected for the study. Following a Baseline examination comprising assessments of oral hygiene status, gingival conditions, probing depths and attachment levels, all participants were subjected to treatment. In each patient, scaling and root planing were carried out in conjunction with the modified Widman flap procedure in two jaw quadrants while in the contralateral quadrants the treatment was restricted to scaling and root planing. During the phase of active treatment, i.e. the period between the first and last operation, and for the subsequent 6 months of healing, the patients were subjected to “professional toothcleaning” once every 2 weeks. From this time until the end of the trial which was 24 months after active treatment, the patients were recalled for prophylaxis once every 3 months. Reexaminations were performed 6, 12 and 24 months after the completion of active treatment. The results demonstrated that scaling and root planing used alone were almost equally effective as their use in combination with the modified Widman flap procedure in establishing clinically healthy gingiva and in preventing further loss of attachment. Both treatment modalities prevented recurrence of periodontal disease for the 24 months of observation. The analysis of the probing depth data revealed that both methods of treatment resulted in a high frequency of probing depths of <4 mm. The probing depth reduction was more pronounced in initially deep than in initially shallow pockets and, for initially deep pockets, more marked in sites subjected to surgery than in sites exposed to scaling and root planing alone. The measurements also showed that sites with initially deep pockets exhibited more pronounced gain of clinical attachment than sites with initially shallow pockets. Significant loss of attachment did not occur in sites treated with scaling and root planing alone while attachment loss was found following Widman flap surgery in sites with initial probing depth of <4 mm.

As the additional use of Emdogain together with coronally advanced flap technique for recession coverage showed no difference in the overall clinical outcome, there is no clear benefit to combine Emdogain with this surgical technique.

Enamel matrix derivative seems to provide better long-term results.