Clinical Outcomes After Treatment of Non‐Contained Intrabony Defects With Enamel Matrix Derivative or Guided Tissue Regeneration: A 12‐Month Randomized Controlled Clinical Trial

Background: The purpose of this study is to compare the healing of deep, non‐contained intrabony defects (i.e., with a ≥80% 1‐wall component and a residual 2‐ to 3‐wall component in the most apical part) treated with either an enamel matrix derivative (EMD) or guided tissue regeneration (GTR) after 12 months. Methods: In this randomized, controlled clinical trial, 40 subjects with 40 defects affecting single‐rooted teeth were treated. The defects were treated with EMD alone or with a non‐resorbable titanium‐reinforced membrane. No grafting materials were used. At baseline and after 12 months, clinical parameters including probing depths (PDs) and clinical attachment levels (CAL) were recorded. The difference in CAL gain was the primary outcome. Results: At baseline, the intrabony component of the defects amounted to 8.5 ± 2.2 mm at EMD‐treated sites and 8.6 ± 1.7 mm at GTR‐treated sites (P = 0.47). The mean CAL gain at sites treated with GTR was significantly greater (P <0.001) than that at sites treated with EMD (4.1 ± 1.4 mm versus 2.4 ± 2.2 mm, respectively). GTR therapy, compared to EMD application alone, significantly (P = 0.01) increased the probability of CAL gain ≥4 mm (79.2% versus 11.3%, respectively) and significantly (P = 0.01) decreased the probability of residual PDs ≥6 mm (3% versus 79.3%, respectively). Conclusion: Although the outcomes of open‐flap debridement alone were not investigated, the application of EMD alone appeared to yield less PD reduction and CAL gain compared to GTR therapy in the treatment of deep, non‐contained intrabony defects.     

Enamel matrix proteins in the regenerative therapy of deep intrabony defects

AIM: This prospective multicentre randomized controlled clinical trial was designed 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 =3mm. 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 clinically 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.     

Clinical outcomes following treatment of human intrabony defects with GTR/bone replacement material or access flap alone. A multicenter randomized controlled clinical trial

AIM: This prospective multicenter randomized controlled clinical trial was designed to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a guided tissue regeneration (GTR)/bone replacement material. MATERIALS AND METHODS: One hundred and twenty-four patients with advanced chronic periodontitis were recruited in 10 centers in seven countries. All patients had at least one intrabony defect of > or = 3 mm. 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, the regenerative material was applied in the test subjects, and omitted in the controls. At baseline and 1 year following the interventions, clinical attachment levels (CALs), probing pocket depths (PPDs), recession, full-mouth plaque scores and full-mouth bleeding scores (FMBS) were assessed. RESULTS: One year after treatment, the test defects gained 3.3 +/- 1.7 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 (3.7 +/- 1.8 mm) when compared with the controls (3.2 +/- 1.5 mm). A multivariate analysis indicated that the treatment, the clinical centers, baseline PPD and baseline FMBS significantly influenced CAL gains. Odds ratios (ORs) of achieving above-median CAL gains were significantly improved by the test procedure (OR = 2.6, 95% CI 1.2-5.4) and by starting with deeper PPD (OR = 1.7, 1.3-2.2) but were decreased by receiving treatment at the worst-performing clinical center (OR = 0.9, 0.76-0.99). CONCLUSIONS: The results of this trial indicated that regenerative periodontal surgery with a GTR/bone replacement material offers an additional benefit in terms of CAL gains, PPD reductions and predictability of outcomes with respect to papilla preservation flaps alone.     

Treatment of intrabony defects with enamel matrix proteins or bioabsorbable membranes. A 4-year follow-up split-mouth study.

BACKGROUND: Treatment with enamel matrix proteins (EMD) and guided tissue regeneration (GTR) with bioabsorbable membranes has been shown to promote periodontal regeneration; however, until now, there were only limited data on the long-term clinical results following these regenerative techniques. Therefore, the aim of the present study was to present the 4-year results following treatment of intrabony defects with EMD or guided tissue regeneration (GTR). METHODS: Twelve patients, each displaying one pair of intrabony defects located contralaterally in the same jaw, were randomly treated with EMD or with GTR by means of bioabsorbable membranes. The following clinical parameters were evaluated at baseline, at 1 year, and at 4 years after treatment: plaque index (P1), gingival index (G1), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). The primary outcome variable was CAL. No statistically significant differences between the groups were found at baseline. Power analysis to determine superiority of EMD treatment showed that the available sample size would yield 70% power to detect a 1 mm difference. RESULTS: The sites treated with EMD demonstrated mean CAL change from 9.8 +/- 2.0 mm to 6.4 +/- 1.6 mm (P<0.001) and to 6.8 +/- 1.8 mm (P<0.001) at 1 and 4 years, respectively. No statistically significant differences were found between the CAL mean at 1 and 4 years postoperatively. The sites treated with GTR showed a mean CAL change from 9.8 +/- 2.3 mm to 6.6 +/- 1.7 mm (P<0.001) at 1 year and to 6.9 +/- 1.8 mm (P<0.001) at 4 years. The CAL change between I and 4 years did not present statistically significant differences. No statistically significant differences in any of the investigated parameters were observed at 1 and 4 years between the treatment groups. CONCLUSIONS: It was concluded that the CAL gain obtained following treatment with EMD or GTR can be maintained over a 4-year period.     

The simplified papilla preservation flap in the regenerative treatment of deep intrabony defects: clinical outcomes and postoperative morbidity.

BACKGROUND: The aims of the present multi-center, randomized, controlled clinical trial were: 1) to compare the efficacy of the simplified papilla preservation flap with and without a barrier membrane in deep intrabony defects; 2) to evaluate the postoperative morbidity and surgical complications; and 3) to preliminarily test the impact of baseline tooth mobility on clinical outcomes. METHODS: This parallel group, randomized, multi-center, controlled clinical trial involved 112 patients in 8 periodontal practices in 4 countries. A deep intrabony defect in each patient was accessed with the simplified papilla preservation flap. In the test defects, a bioabsorbable membrane was positioned. Patients' experiences with the surgical procedure and postoperative period were evaluated with a questionnaire. Clinical outcomes included clinical attachment level (CAL) and probing depth (PD) changes. RESULTS: Complete observations were available for 55 test and 54 control defects. CAL gains at 1 year were 3.5 +/- 2.1 mm in the guided tissue regeneration (GTR) group and 2.6 +/- 1.8 mm in the control group (P = 0.0117). CAL gains > or = 4 mm were observed in 50.9% of GTR sites and 33.3% of control sites. A significant center effect of 2.1 mm was observed (P= 0.01). Initial PD (P= 0.01) and baseline tooth mobility (P= 0.036) were significant covariates. During the procedure, 30.4% of test and 28.6% of controls reported feeling moderate pain, and subjects estimated the hardship of the procedure at 24 +/- 25 visual analog scale (VAS) units in the test group, and at 22 +/- 23 VAS in controls. In terms of the investigated outcomes, differences between test and control groups were not statistically significant. Among the postoperative complications, edema was most prevalent at week 1, and more frequently associated with the test treatment (P= 0.01). In the test group, 53.6% of membranes were exposed at week 3. CONCLUSIONS: The present study further supports the added benefits of guided tissue regeneration with respect to access flap alone in the treatment of deep intrabony defects, as well as the general efficacy of GTR in different clinical settings. Furthermore, our study indicates a possible influence of baseline tooth mobility on clinical outcomes.     

Treatment of intrabony defects with an enamel matrix protein derivative or bioabsorbable membrane: an 8-year follow-up split-mouth study

BACKGROUND: Treatments with either an enamel matrix protein derivative (EMD) or guided tissue regeneration (GTR) have been shown to promote periodontal regeneration. However, until recently, only limited data have been available on the long-term clinical results following these regenerative techniques. Therefore, the aim of this study was to present the 8-year results of a prospective, controlled, split-mouth clinical study evaluating the treatment of intrabony defects with EMD or GTR. METHODS: Ten patients, each of whom displayed one pair of intrabony defects located contralaterally in the same jaw, were randomly treated with EMD or with GTR by means of bioabsorbable membranes. The following clinical parameters were evaluated at baseline and at 1 and 8 years after treatment: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). The primary outcome variable was CAL. No statistically significant differences between the groups were found at baseline. RESULTS: The sites treated with EMD demonstrated a mean CAL change from 9.5 +/- 1.2 mm to 6.3 +/- 1.3 mm (P <0.001) and 6.7 +/- 1.6 mm (P <0.001) at 1 and 8 years, respectively. No statistically significant differences were found between the 1- and 8-year results. Sites treated with GTR showed a mean CAL change from 9.7 +/- 1.3 mm to 6.7 +/- 0.9 mm (P <0.001) at 1 year and 6.8 +/- 1.2 mm (P <0.001) at 8 years. The CAL change between 1 and 8 years did not present statistically significant differences. Between the treatment groups, no statistically significant differences in any of the investigated parameters were observed at 1 and at 8 years. However, the study does not have the statistical power to rule out the possibility of a difference between the two groups. CONCLUSIONS: Within their limits, the present results indicate the following: 1) the clinical improvements obtained following treatment with EMD or GTR can be maintained over a period of 8 years; and 2) further studies of much higher power need to be performed to support equivalence.     

Treatment of wide, shallow, and predominantly 1-wall intrabony defects with a bioabsorbable membrane: a randomized controlled clinical trial

BACKGROUND: The regenerative therapy of non-contained intrabony defects achieves better results when bioabsorbable membranes are combined with a filling material. The purpose of the present study was to analyze clinical and radiographic effectiveness of a space-making bioabsorbable membrane in the treatment of wide and shallow intrabony defects characterized by a relevant 1-wall component. METHODS: Eighteen pairs of angular bone defects were selected in 18 healthy, non-smoking patients (age range 30 to 66 years). Prior to the surgical phase, patients were enrolled in a strict periodontal program including oral hygiene instructions and scaling and root planing (presurgical full-mouth plaque score <10%). Using a split-mouth design, 18 sites were randomly assigned to receive guided tissue regeneration (GTR) using a bioabsorbable membrane (test group) and 18 to receive open flap debridement alone (control group). Clinical treatment outcome was evaluated 12 months postoperatively for changes in probing depth (PD), clinical attachment level (CAL), and position of gingival margin (REC) and radiographically for bone changes. Results: Open flap debridement and GTR yielded statistically significant (P<0.0001) PD reduction (2.39+/- 0.92 mm and 3.44+/- 0.78 mm), CAL gain (1.50+/- 0.99 mm and 2.89 +/- 0.90 mm), increased REC (-0.89 +/- 0.58 mm and -0.56 +/- 0.92 mm) and bone fill (1.05+/- 0.94 mm and 2.13+/- 1.21 mm) when 12-month data were compared to baseline. The differences between test and control groups were statistically significant for all parameters (P<0.007) except for REC (P=0.25). CONCLUSION: The use of this bioabsorbable membrane would seem to be effective in the treatment of intrabony defects with unfavorable architecture without the use of filling materials.     

Effect of platelet-rich plasma on the healing of intra-bony defects treated with a natural bone mineral and a collagen membrane

BACKGROUND: Regenerative periodontal therapy with a combination of platelet-rich plasma (PRP)+a natural bone mineral (NBM)+guided tissue regeneration (GTR) has been shown to result in significantly higher probing depth reductions and clinical attachment-level gains compared with treatment with open flap debridement alone. However, at present, it is unknown to what extent the use of PRP may additionally enhance the clinical outcome of the therapy compared with treatment with NBM+GTR. AIM: To clinically compare treatment of deep intra-bony defects with NBM+PRP+GTR with NBM+GTR. MATERIAL AND METHODS: Thirty patients suffering from advanced periodontal disease, and each of whom displayed one advanced intra-bony defect were randomly treated with a combination of either NBM+PRP+collagen membrane (GTR) or NBM+GTR. The following clinical parameters were evaluated at baseline and at 1 year after treatment: plaque index, gingival index, bleeding on probing, probing depth (PD), gingival recession and clinical attachment level (CAL). CAL changes were used as the primary outcome variable. RESULTS: No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. At 1 year after therapy, the sites treated with NBM+PRP+GTR showed a reduction in mean PD from 8.9+/-2.3 mm to 3.4+/-2.0 mm (p<0.001) and a change in mean CAL from 10.9+/-2.2 mm to 6.4+/-1.8 mm (p<0.001). In the group treated with NBM+GTR, the mean PD was reduced from 8.9+/-2.5 mm to 3.4+/-2.3 mm (p<0.001), and the mean CAL changed from 11.1+/-2.5 mm to 6.5+/-2.3 mm (p<0.001). In both groups, all sites gained at least 3 mm of CAL. CAL gains of > or = 4 mm were measured in 80% (i.e. in 12 out of 15 defects) of the cases treated with NBM+PRP+GTR and in 87% (i.e. in 13 out of 15 defects) treated with NBM+GTR. No statistically significant differences in any of the investigated parameters were observed between the two groups. CONCLUSIONS: Within its limits, the present study has shown that (i) at 1 year after regenerative surgery with both NBM+PRP+GTR and NBM+GTR, significant PD reductions and CAL gains were found, and (ii) the use of PRP has failed to improve the results obtained with NBM+GTR.     

Effect of platelet-rich plasma on the healing of intrabony defects treated with Beta tricalcium phosphate and expanded polytetrafluoroethylene membranes

BACKGROUND: Regenerative periodontal therapy using platelet-rich plasma (PRP) and different types of bone substitutes with or without guided tissue regeneration (GTR) has been proposed as a modality to enhance the outcome of regenerative surgery. However, there are limited data from controlled clinical studies evaluating the effect of PRP on the healing of deep intrabony defects treated with a combination of bone substitutes and GTR. The aim of this study was to clinically evaluate the effect of PRP on the healing of deep intrabony defects treated with beta tricalcium phosphate (beta-TCP) and GTR by means of a non-bioresorbable expanded polytetrafluoroethylene membrane. METHODS: Twenty-eight subjects with advanced chronic periodontal disease and displaying one intrabony defect were treated randomly with a combination of PRP + beta-TCP + GTR or beta-TCP + GTR. Plaque index, gingival index, bleeding on probing, probing depth (PD), gingival recession, and clinical attachment level (CAL) were evaluated at baseline and at 1 year after treatment. CAL was the primary outcome variable. RESULTS: No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all subjects. At 1 year after therapy, the sites treated with PRP + beta-TCP + GTR showed a reduction in mean PD from 9.1 +/- 0.6 mm to 3.3 +/- 0.5 mm (P <0.001) and a change in mean CAL from 10.1 +/- 1.3 mm to 5.7 +/- 1.1 mm (P <0.001). In the group treated with beta-TCP + GTR, mean PD was reduced from 9.0 +/- 0.8 mm to 3.6 +/- 0.9 mm (P <0.001), and the mean CAL changed from 9.9 +/- 1.0 mm to 5.9 +/- 1.2 mm (P <0.001). In both groups, all sites gained > or =3 mm of CAL. CAL gains > or =4 mm were noted in 86% (12 of 14 defects) of the cases treated with PRP + beta-TCP + GTR and in 79% (11 of 14 defects) of those treated with beta-TCP + GTR. No statistically significant differences in any of the investigated parameters were observed between the two groups at the 1-year reevaluation. CONCLUSION: At 1 year after surgery, both therapies resulted in significant PD reductions and CAL gains.     

Effect of platelet-rich plasma on the healing of intrabony defects treated with an anorganic bovine bone mineral and expanded polytetrafluoroethylene membranes

BACKGROUND: Regenerative periodontal therapy with a combination of platelet-rich plasma (PRP) + an anorganic bovine bone mineral (ABBM) + guided tissue regeneration (GTR) has been shown to result in significantly higher probing depth reductions and clinical attachment level gains compared to treatment with open flap debridement (OFD) alone, ABBM alone, or GTR alone. However, there are no data evaluating to what extent the use of PRP may additionally enhance the clinical outcome of the therapy compared to treatment with ABBM + GTR. This study aimed to clinically evaluate the effect of PRP on the healing of deep intrabony defects treated with ABBM and GTR by means of a non-resorbable expanded polytetrafluoroethylene (ePTFE) membrane. METHODS: Twenty-four patients with advanced chronic periodontal disease and displaying one intrabony defect were randomly treated with a combination of either PRP + ABBM + GTR or ABBM + GTR. The following clinical parameters were evaluated at baseline and at 1 year after treatment: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). The primary outcome variable was CAL. RESULTS: No differences in any of the studied parameters were observed at baseline between the two groups. Healing was uneventful in all patients. At 1 year after therapy, the sites treated with PRP + ABBM + GTR showed a reduction in mean PD from 8.6 +/- 1.7 mm to 3.1 +/- 1.3 mm (P <0.001) and a change in mean CAL from 10.3 +/- 1.4 mm to 5.7 +/- 1.6 mm (P <0.001). In the group treated with ABBM + GTR, mean PD was reduced from 8.8 +/- 1.7 mm to 3.1 +/- 1.0 mm (P <0.001), and the mean CAL changed from 10.4 +/- 2.6 mm to 5.9 +/- 1.8 mm (P <0.001). In both groups, all sites gained > or =3 mm of CAL. CAL gains > or =4 mm were measured in 83% (i.e., in 10 of 12 defects) of the cases treated with PRP + ABBM + GTR and in 92% (i.e., in 11 of 12 defects) treated with ABBM + GTR. No statistically significant differences in any of the studied parameters were observed between the two groups at 1-year reevaluation. CONCLUSION: Within its limits, the present study has shown that, at 1 year after regenerative therapy in periodontal intrabony defects, optimal clinical results were obtained with ABBM + GTR with a non-resorbable barrier, with or without the addition of PRP.     

Five-year results of a prospective, randomized, controlled study evaluating treatment of intra-bony defects with a natural bone mineral and GTR

BACKGROUND: Treatment with a natural bone mineral (NBM) and a guided tissue regeneration (GTR) has been shown to promote periodontal regeneration. However, until now there are only very limited data on the long-term clinical results following this regenerative technique. AIM: To present the 5-year results of a prospective, randomized, controlled clinical study evaluating the treatment of deep intra-bony defects either with open flap debridement (OFD) and a combination of an NBM and GTR (test) or OFD alone (control). METHODS: Nineteen patients diagnosed with advanced chronic periodontitis, and each of whom displayed one intra-bony defect, received randomly the test or the control treatment. Results were evaluated at baseline, at 1 and at 5 years following therapy. RESULTS: No statistically significant differences in any of the investigated parameters were observed at baseline between the two groups. At 1 year after therapy, the test group showed a reduction in mean probing depth (PD) from 9.1+/-1.1 to 3.7+/-0.8 mm (p<0.001) and a change in mean clinical attachment level (CAL) from 10.4+/-1.3 to 6.4+/-1.2 mm (p<0.001). At 5 years, mean PD and CAL measured 4.3+/-0.8 and 6.7+/-1.6 mm, respectively. At 5 years, both PD and CAL were statistically significantly improved compared with baseline (p<0.001) without statistically significant differences between the 1- and 5-year results. In the control group, mean PD was reduced from 8.9+/-1.3 to 4.9+/-1.2 mm (p<0.001) and mean CAL changed from 10.6+/-1.4 to 8.8+/-1.5 mm (p<0.01). At 5 years, mean PD and CAL measured 5.6+/-1.1 and 9.1+/-1.3 mm, respectively, and were still statistically significantly improved compared with baseline (p<0.01). No statistically significant differences were found between the 1- and 5-year results. The test treatment, at both 1 and 5 years, yielded statistically significantly higher CAL gains than the control one (p<0.01). Compared with baseline, at 5 years a CAL gain of > or =3 mm was found in nine defects (90%) of the test group but in none of the defects treated with OFD alone. CONCLUSIONS: It was concluded that (i) treatment of intra-bony defects with OFD+NBM+GTR may result in significantly higher CAL gains than treatment with OFD, and (ii) the clinical results obtained after both treatments can be maintained over a period of 5 years.     

Comparison of clinical, radiographic, and histometric measurements following treatment with guided tissue regeneration or enamel matrix proteins in human periodontal defects

BACKGROUND: The purpose of this study was to compare the clinical and radiographic parameters with the histometric findings following 2 different regenerative procedures in humans. METHODS: Fourteen advanced intrabony defects at teeth scheduled for extraction were randomly treated as follows: 8 with guided tissue regeneration (GTR) using bioabsorbable barriers and 6 with an enamel matrix protein derivative (EMD). Standardized radiographs, probing depths (PD), and attachment levels (CAL) at baseline and 6 months after therapy were evaluated and compared to the histometric measurements made following the removal of teeth and surrounding tissues 6 months after the surgery. RESULTS: Significant PD reductions (GTR: -5.62 mm; EMD: -5.00 mm) and CAL gains (GTR: 3.87 mm; EMD: 2.67 mm) were observed in both groups. Six months after surgery, minor resorptions of the alveolar crest (AC) (GTR: 0.40 mm; EMD: 0.33 mm) and bony gain at the bottom of the defects (GTR: 0.47 mm; EMD: 1.05 mm) were observed radiographically. No statistically significant differences in the change of clinical and radiographic parameters between the GTR and EMD groups were found. Histometrically, significant amounts of new connective tissue attachment (i.e., cementum with inserting collagen fibers) were observed in both groups (GTR: 2.29 mm; EMD: 1.81 mm). Bone regeneration was found to be significant only in the GTR group (GTR: 1.93 mm; EMD: 0.78 mm). However, the study lacked statistical power for determining equivalence between the groups. CONCLUSIONS: Within the limitations of the present study, it may be concluded that at 6 months after GTR or enamel matrix protein derivative therapy, formation of new cementum and bone may be histometrically demonstrated. Except for the formation of new bone, no statistically significant differences between both therapies could be seen for clinical, radiographic, and histometric results 6 months after surgery.     

Healing of human intrabony defects following regenerative periodontal therapy with an enamel matrix protein derivative alone or combined with a bioactive glass. A controlled clinical study

AIM: The purpose of the present study was to compare clinically the treatment of deep intrabony defects with a combination of an enamel matrix protein derivative (EMD) and a bioactive glass (BG) to EMD alone. METHODS: Thirty patients (16 females and 14 males) suffering from advanced marginal periodontitis were included in this prospective, controlled parallel design multicenter study. In each of the patients, one intrabony defect was randomly treated with either EMD+BG (test) or with EMD alone (control). Clinical measurements were recorded at baseline and at 1 year following therapy. RESULTS: No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. At 1 year after therapy, the test group showed a reduction in mean probing depth (PD) from 8.5+/-1.1 to 4.4+/-1.2 mm (p<0.001) and a change in mean clinical attachment level (CAL) from 10.4+/-1.5 to 7.1+/-1.5 mm (p<0.0001). In the control group, the mean PD was reduced from 8.5+/-1.5 to 4.0+/-1.6 mm (p<0.001) and the mean CAL changed from 10.2+/-2.1 to 6.3+/-2.2 mm (p<0.01). In the test group, 12 sites (80%) gained at least 3 mm or more of CAL, whereas in the control group a CAL gain of 3 mm or more was measured at 13 sites (87%). No statistically significant differences in terms of PD reduction and CAL gain were found between the test and the control treatment. CONCLUSIONS: Within the limits of the present study it can be concluded that: (i) at 1 year after surgery, both therapies resulted in significant PD reductions and CAL gains, and (ii) the combination of EMD+BG does not seem to additionally improve the clinical results.     

Five-year results following treatment of intrabony defects with enamel matrix proteins and guided tissue regeneration

BACKGROUND: Treatment with enamel matrix proteins (EMD) or guided tissue regeneration (GTR) has been shown to enhance periodontal regeneration. However, until now there are limited data on the long-term results following these treatment modalities. Aim: The aim of the present clinical study was to present the 5-year results following treatment of intrabony defects with EMD, GTR, combination of EMD and GTR, and open flap debridement (OFD). MATERIAL AND METHODS: Forty-two patients, each of whom displayed one intrabony defect of a probing depth of at least 6 mm, were randomly treated with one of the four treatment modalities. The following parameters were evaluated prior to surgery, at 1 year and at 5 years after: plaque index, gingival index, bleeding on probing, probing pocket depth (PPD), gingival recession, and clinical attachment level (CAL). No statistically significant differences in any of the parameters were observed at baseline between the four groups. RESULTS: The sites treated with EMD demonstrated a mean CAL gain of 3.4+/-1.1 mm (p<0.001) and of 2.9+/-1.6 mm (p<0.001) at 1 and 5 years, respectively. The sites treated with GTR showed a mean CAL gain of 3.2+/-0.8 (p<0.001) at 1 year and of 2.7+/-0.9 mm (p<0.001) at 5 years. The mean CAL gain at sites treated with EMD+GTR was 3.0+/-1.0 mm (p<0.001) and 2.6+/-0.7 mm (p<0.001) at 1 and 5 years, respectively. The sites treated with OFD demonstrated a mean CAL gain of 1.6+/-1.0 mm (p<0.001) at 1 year and 1.3+/-1.2 mm (p<0.001) at 5 years. At 1 year, the only statistically significant difference between the four different treatments was found in terms of PPD reduction and CAL gain between EMD and OFD (p<0.05). However, at 5 years there were no statistically significant differences in any of the investigated parameters between the four different treatments. CONCLUSION: Within the limits of the present study, it may be concluded that the short-term clinical results following treatment with EMD, GTR, EMD+GTR, and OFD can be maintained over a period of 5 years.     

Effect of autogenous cortical bone particulate in conjunction with enamel matrix derivative in the treatment of periodontal intraosseous defects

BACKGROUND: The aim of the present study was to assess the additional clinical benefit of autogenous cortical bone particulate (ACBP) when added to enamel matrix derivative (EMD), compared to EMD alone, in the treatment of deep periodontal intraosseous defects. METHODS: A total of 28 intraosseous lesions in 27 patients with advanced periodontitis were included in this controlled clinical trial and randomly assigned to the EMD group (14 defects) or to the EMD + ACBP group (14 defects). Immediately before surgery (baseline) and after 6 and 12 months, probing depth (PD), clinical attachment level (CAL), and gingival recession (REC) were recorded. Radiographic depth of the defect (DEPTH) was also measured at baseline and 12 months post-surgery. RESULTS: At 6 and 12 months, PD and CAL significantly improved from baseline in both groups (P <0.000). No significant differences in terms of CAL gain and PD reduction were detected between groups. However, defect distribution according to CAL gain was significantly different between groups (P <0.05). DEPTH significantly decreased from baseline to 12 months in both groups (P <0.000); between-group differences were not significant. At 12 months, a significantly greater REC increase in the EMD group (1.1 +/- 0.7 mm) compared to the EMD + ACBP group (0.3 +/- 0.8 mm) was observed (P <0.05). CONCLUSIONS: Both EMD and EMD + ACBP treatments led to a significant improvement in clinical and radiographic parameters at follow-up with respect to presurgery condition. The combined approach resulted in reduced post-surgery recession and increased proportion of defects with substantial CAL gain (> or = 6 mm).     

Nine-year results following treatment of intrabony periodontal defects with an enamel matrix derivative: report of 26 cases

Treatment of intrabony periodontal defects with an enamel matrix derivative (EMD) has been demonstrated, in the short term, to result in periodontal regeneration and to significantly improve clinical parameters such as probing depth (PD) and clinical attachment level (CAL). The present study evaluated deep intrabony defect sites at 9 years after treatment with EMD. Twenty-one patients with a total of 26 deep intrabony defects with PD > or = 6 mm and intrabony depth > or = 3 mm, as identified by probing and radiographs, were consecutively treated with EMD. PD, recession of the gingival margin (GR), and CAL were evaluated prior to treatment and at 1 and 9 years after treatment. At 1 year, mean PD was significantly reduced. At 9 years, mean PD was statistically significantly increased versus the 1-year results but still significantly improved versus baseline. After I year, mean GR had increased significantly; at 9 years, measurements showed statistically significant improvements compared to the 1-year results and baseline. The mean CAL changed from 10.0 +/- 2.3 mm at baseline to 6.8 +/- 2.3 mm at 1 year and to 7.0 +/- 1.9 mm at 9 years. No treated teeth were lost during the observation period. The clinical improvements obtained following treatment with EMD can be maintained over a period of 9 years.     

Treatment of intrabony defects with enamel matrix proteins and guided tissue regeneration. A prospective controlled clinical study

BACKGROUND: Utilisation of enamel matrix proteins (EMD) and application of the guided tissue regeneration principle (GTR) are treatment modalities which both have been shown to result in periodontal regeneration. However, it is yet unknown whether the combination of EMD and GTR may additionally favor the regeneration process. AIM: The aim of the present controlled study was to evaluate clinically the treatment effect of EMD, GTR, combination of EMD and GTR, and flap surgery (control) on intrabony defects. MATERIAL AND METHODS: 56 patients each of whom displaying one intrabony defect of a depth of at least 6 mm were randomly treated with one of the treatment modalities. Prior to surgery and at one year after, the following parameters were evaluated by a blinded examiner: Plaque index (PlI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), gingival recession (GR) and clinical attachment level (CAL). No statistical significant differences between the four groups were observed at baseline for any of the investigated parameters. RESULTS: At 1 year after therapy, the sites treated with EMD demonstrated a mean PPD reduction of 4.1 +/- 1.7 mm and a mean CAL gain of 3.4 +/- 1.5 mm (p<0.001). The sites treated with GTR showed a mean PPD reduction of 4.2 +/- 1.9 mm and a mean CAL gain of 3.1 +/- 1.5 mm (p<0.001). The sites treated with the combined treatment showed a mean PPD reduction of 4.3 +/- 1.4 mm and a mean CAL gain of 3.4 +/- 1.1 mm (p<0.001). In the control group, the mean PPD reduction was 3.7 +/- 1.4 mm (p<0.001) and the mean CAL gain measured 1.7 +/- 1.5 mm (p<0.01). All 4 treatments led to statistically significant PPD reduction and CAL gain. All three regenerative treatments led to higher CAL gain than the control treatment (p<0.05). No statistical significant differences in PPD reduction and CAL gain were observed between the three regenerative treatments. CONCLUSION: It may be concluded that (a) all 3 regenerative treatment modalities may lead to higher CAL gain than the control one, and (b) the combined treatment does not seem to improve the outcome of the regenerative procedure.     

Healing of intra-bony defects following treatment with a composite bovine-derived xenograft (Bio-Oss Collagen) in combination with a collagen membrane (Bio-Gide PERIO)

AIM: The purpose of the present study was to compare clinically the treatment of deep intra-bony defects with a combination of a composite bovine-derived xenograft (BDX Coll) and a bioresorbable collagen membrane [guided tissue regeneration (GTR)] to access flap surgery only. METHODS: Thirty-two patients, each of whom displayed one intra-bony defect, were treated either with BDX Coll+GTR (test) or with access flap surgery (control). The results were evaluated at 1 year following therapy. RESULTS: No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. At 1 year after therapy, the test group showed a reduction in the mean probing depth (PD) from 8.3+/-1.5 to 2.9+/-1.3 mm (p<0.001) and a change in the mean clinical attachment level (CAL) from 9.4+/-1.3 to 5.3+/-1.5 mm (p<0.0001). In the control group, the mean PD was reduced from 8.0+/-1.2 to 4.4+/-1.7 mm (p<0.001) and the mean CAL changed from 9.6+/-1.3 to 7.9+/-1.6 mm (p<0.01). The test treatment resulted in statistically higher PD reductions (p< or =0.05) and CAL gains (p<0.001) than the control one. In the test group, all sites (100%) gained at least 3 mm of CAL. In this group, a CAL gain of 3 or 4 mm was measured at 10 sites (62%), whereas at six sites (38%), the CAL gain was 5 or 6 mm. In the control group, no CAL gain occurred at three sites (19%), whereas at 10 sites (62%), the CAL gain was only 1 or 2 mm. A CAL gain of 3 mm was measured in three defects (19%). CONCLUSIONS: Within the limits of the present study, it can be concluded that the combination of BDX Coll+GTR resulted in significantly higher CAL gains than treatment with access flap surgery alone, and thus appears to be a suitable alternative for treating intra-bony periodontal defects.     

Clinical Outcomes Following Regenerative Therapy of Non‐Contained Intrabony Defects Using a Deproteinized Bovine Bone Mineral Combined With Either Enamel Matrix Derivative or Collagen Membrane

Background: The purpose of this study is to compare clinical outcomes in the treatment of deep non‐contained intrabony defects (i.e., with ≥70% 1‐wall component and a residual 2‐ to 3‐wall component in the most apical part) using deproteinized bovine bone mineral (DBBM) combined with either enamel matrix protein derivative (EMD) or collagen membrane (CM). Methods: Forty patients with multiple intrabony defects were enrolled. Only one non‐contained defect per patient with an intrabony depth ≥3 mm located in the interproximal area of single‐ and multirooted teeth was randomly assigned to the treatment with either EMD + DBBM (test: n = 20) or CM + DBBM (control: n = 20). At baseline and after 12 months, clinical parameters including probing depth (PD) and clinical attachment level (CAL) were recorded. The primary outcome variable was the change in CAL between baseline and 12 months. Results: At baseline, the intrabony component of the defects amounted to 6.1 ± 1.9 mm for EMD + DBBM and 6.0 ± 1.9 mm for CM + DBBM sites (P = 0.81). The mean CAL gain at sites treated with EMD + DBBM was not statistically significantly different (P = 0.82) compared with CM + DBBM (3.8 ± 1.5 versus 3.7 ± 1.2 mm). No statistically significant difference (P = 0.62) was observed comparing the frequency of CAL gain ≥4 mm between EMD + DBBM (60%) and CM + DBBM (50%) or comparing the frequency of residual PD ≥6 mm between EMD + DBBM (5%) and CM + DBBM (15%) (P = 0.21). Conclusion: Within the limitations of the present study, regenerative therapy using either EMD + DBBM or CM + DBBM yielded comparable clinical outcomes in deep non‐contained intrabony defects after 12 months.     

The effect of postsurgical antibiotics on the healing of intrabony defects following treatment with enamel matrix proteins

BACKGROUND: Regenerative treatment with enamel matrix proteins has been shown to promote healing in intrabony defects. However, up to now various postoperative antibiotic regimens have been used in combination with enamel matrix proteins and therefore it cannot be excluded that the results may also be attributable to the effect of the antibiotic treatment. The aim of this randomized, controlled, blinded, clinical investigation was to determine the effect of postsurgical administration of antibiotics on the healing of intrabony periodontal defects treated with enamel matrix proteins. METHODS: Thirty-four patients each of whom exhibited one deep intrabony defect were randomly treated with either enamel matrix proteins plus antibiotics (test: EMD + AB) or with enamel matrix proteins alone (control: EMD). The antibiotic regimen consisted of a combination of 3 x 375 mg amoxicillin and 3 x 250 mg metronidazole daily for 7 days. The following parameters were recorded at baseline and at 1 year by the same calibrated and blinded investigator: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). Power analysis to determine superiority of antibiotic treatment showed that the available sample size would yield 85% power to detect a 1 mm difference. RESULTS: No statistically significant differences in any of the investigated parameters between the 2 groups were observed at baseline. No serious adverse events such as allergic reactions or abscesses after any of the treatments were observed during the entire study period. The results have shown that in the EMD + AB group the PD decreased from 9.1 +/- 1.5 mm to 4.5 +/- 1.1 mm (P<0.0001) and the CAL changed from 11.0 +/- 1.6 mm to 7.5 +/- 1.4 mm (P<0.0001). In the EMD group the PD decreased from 9.0 +/- 1.7 mm to 4.3 +/- 1.7 mm (P <0.0001) and the CAL changed from 10.6 +/- 1.6 mm to 7.3 +/- 1.5 mm (P <0.0001). There were no significant differences in any of the investigated parameters between the 2 groups. CONCLUSIONS: It can be concluded that the systemic administration of amoxicillin and metronidazole adjacent to the use of EMD for the surgical treatment of intrabony periodontal defects does not produce statistically superior PD reduction and CAL gain when compared to treatment with EMD alone. Hence, the present results do not support the routine administration of amoxicillin and metronidazole following regenerative treatment with EMD.