BACKGROUND: The aim of this 5-year randomized controlled clinical trial was to evaluate the long-term results after guided tissue regeneration (GTR) therapy of infrabony defects using two bioabsorbable barriers. METHODS: Fifteen pairs of contralateral infrabony defects in 15 patients with moderate to severe periodontitis were treated. Each patient received one polydioxanon (test: T) and one polylactide acetyltributyl citrate (control: C) barrier by random assignment. At baseline, 12, and 60 +/- 3 months after surgery clinical parameters and standardized radiographs were obtained. Vertical bone levels (PBL-V) were measured during surgery and 60 +/- 3 months later by transgingival bone sounding. RESULTS:Thirteen patients were available for the 60-month examinations. Twelve and 60 +/- 3 months after GTR, statistically significant (P< or =0.001) vertical attachment (CAL-V) gain was found in both groups (T12: 3.5 +/- 1.5 mm; T60: 2.2 +/- 1.8 mm; C12: 4.0 +/- 0.9 mm; C60: 2.4 +/- 1.0 mm). However, from 12 to 60 months after therapy both groups experienced significant CAL-V loss (P<0.05): two defects in the test group and three in the control group had CAL-V loss >2 mm compared to the 12-month reexamination. Twelve and 60 +/- 3 months after surgery, statistically significant (P<0.05) radiographic bony fill was found in both groups (T12: 1.2 +/- 1.3 mm; T60: 1.5 +/- 2.2 mm; C12: 0.9 +/- 1.4 mm; C60: 1.0 +/- 1.6 mm). Further, 60 months after surgery significant (P<0.05) PBL-V gain was found in both groups (test: 1.8 +/- 2.3 mm; control: 2.2 +/- 1.8 mm). The study failed to show statistically significant differences between test and control regarding CAL-V and PBL-V gain 60 months after surgery. CONCLUSION: CAL-V gain achieved after GTR therapy in infrabony defects using both bioabsorbable barriers was stable after 5 years in 21 of 26 defects (81%).
RCT Entities:
BACKGROUND: The aim of this 5-year randomized controlled clinical trial was to evaluate the long-term results after guided tissue regeneration (GTR) therapy of infrabony defects using two bioabsorbable barriers. METHODS: Fifteen pairs of contralateral infrabony defects in 15 patients with moderate to severe periodontitis were treated. Each patient received one polydioxanon (test: T) and one polylactide acetyltributyl citrate (control: C) barrier by random assignment. At baseline, 12, and 60 +/- 3 months after surgery clinical parameters and standardized radiographs were obtained. Vertical bone levels (PBL-V) were measured during surgery and 60 +/- 3 months later by transgingival bone sounding. RESULTS: Thirteen patients were available for the 60-month examinations. Twelve and 60 +/- 3 months after GTR, statistically significant (P< or =0.001) vertical attachment (CAL-V) gain was found in both groups (T12: 3.5 +/- 1.5 mm; T60: 2.2 +/- 1.8 mm; C12: 4.0 +/- 0.9 mm; C60: 2.4 +/- 1.0 mm). However, from 12 to 60 months after therapy both groups experienced significant CAL-V loss (P<0.05): two defects in the test group and three in the control group had CAL-V loss >2 mm compared to the 12-month reexamination. Twelve and 60 +/- 3 months after surgery, statistically significant (P<0.05) radiographic bony fill was found in both groups (T12: 1.2 +/- 1.3 mm; T60: 1.5 +/- 2.2 mm; C12: 0.9 +/- 1.4 mm; C60: 1.0 +/- 1.6 mm). Further, 60 months after surgery significant (P<0.05) PBL-V gain was found in both groups (test: 1.8 +/- 2.3 mm; control: 2.2 +/- 1.8 mm). The study failed to show statistically significant differences between test and control regarding CAL-V and PBL-V gain 60 months after surgery. CONCLUSION: CAL-V gain achieved after GTR therapy in infrabony defects using both bioabsorbable barriers was stable after 5 years in 21 of 26 defects (81%).