N J López1, J A Gamonal, B Martinez. 1. Department of Conservative Dentistry, Faculty of Dentistry, University of Chile, Santiago. nlopez@interactiva.cl
Abstract
BACKGROUND: The prevailing concept is that little or no clear benefit is derived from antibiotic therapy in chronic periodontitis. Studies to determine the effect of metronidazole plus amoxicillin (M+A) on adult periodontitis are questionable because standard design for clinical trials was usually not used. In addition, there is no information about the effect of M+A as the sole therapy for periodontitis. METHODS: A randomized, triple-blind, controlled clinical trial was used to determine the effect of systemic administration of M+A, as the sole therapy, in progressive adult periodontitis. Forty-six subjects with moderate to advanced adult periodontitis who showed > or =2 mm attachment loss in at least 2 sites in the previous 2 months were entered in the study. Subjects were randomly distributed to a group who received 21 tablets of metronidazole 250 mg plus amoxicillin 500 mg, or to a group receiving a placebo (1 tablet every 8 hours for 1 week). Patients were examined every 2 months for 12 months. The M+A or placebo regimen was repeated at 4 and 8 months. No effort was made to change the oral habits of patients and they received no additional therapy. Differences between groups were assessed using the Mann-Whitney U test. The differences at every 2-month interval within each group were assessed using the ANOVA test. RESULTS: Seven subjects abandoned the study; at 12 months the M+A group had 20 subjects and the placebo group 19. There were no significant differences in the clinical parameters at baseline between the 2 groups. After 2 months and thereafter, the M+A group showed significant clinical improvement while the placebo group showed a progressive deterioration of periodontal status. At 12 months compared to baseline, subjects of the M+A group showed: 1) a significant overall mean attachment gain of 0.43 mm (P = 0.005); 2) a significant decrease of active sites (P< or =0.03); 3) a significant increase of sites gaining attachment level (P< or =0.01); 4) a significant reduction of pocket depth (P< or =0.00006); and 5) a significant decrease in percentage of bleeding on probing sites (BOP) (P< or =0.0005). Significant differences between both groups at all 2-month evaluations were found in overall mean attachment level (P < or =0.000004), in percent of active sites (P< or =0.03), and in percent of BOP sites (P< or =0.02). Sites exhibiting > or =2 mm of attachment loss in 2 successive or alternate evaluations, and periodontal abscess were noticed only in the placebo group. CONCLUSIONS: A 1-week course of systemic M+A every 4 months, as the only therapy, arrests the progression of adult periodontitis and significantly improves the clinical parameters of the disease.
RCT Entities:
BACKGROUND: The prevailing concept is that little or no clear benefit is derived from antibiotic therapy in chronic periodontitis. Studies to determine the effect of metronidazole plus amoxicillin (M+A) on adult periodontitis are questionable because standard design for clinical trials was usually not used. In addition, there is no information about the effect of M+A as the sole therapy for periodontitis. METHODS: A randomized, triple-blind, controlled clinical trial was used to determine the effect of systemic administration of M+A, as the sole therapy, in progressive adult periodontitis. Forty-six subjects with moderate to advanced adult periodontitis who showed > or =2 mm attachment loss in at least 2 sites in the previous 2 months were entered in the study. Subjects were randomly distributed to a group who received 21 tablets of metronidazole 250 mg plus amoxicillin 500 mg, or to a group receiving a placebo (1 tablet every 8 hours for 1 week). Patients were examined every 2 months for 12 months. The M+A or placebo regimen was repeated at 4 and 8 months. No effort was made to change the oral habits of patients and they received no additional therapy. Differences between groups were assessed using the Mann-Whitney U test. The differences at every 2-month interval within each group were assessed using the ANOVA test. RESULTS: Seven subjects abandoned the study; at 12 months the M+A group had 20 subjects and the placebo group 19. There were no significant differences in the clinical parameters at baseline between the 2 groups. After 2 months and thereafter, the M+A group showed significant clinical improvement while the placebo group showed a progressive deterioration of periodontal status. At 12 months compared to baseline, subjects of the M+A group showed: 1) a significant overall mean attachment gain of 0.43 mm (P = 0.005); 2) a significant decrease of active sites (P< or =0.03); 3) a significant increase of sites gaining attachment level (P< or =0.01); 4) a significant reduction of pocket depth (P< or =0.00006); and 5) a significant decrease in percentage of bleeding on probing sites (BOP) (P< or =0.0005). Significant differences between both groups at all 2-month evaluations were found in overall mean attachment level (P < or =0.000004), in percent of active sites (P< or =0.03), and in percent of BOP sites (P< or =0.02). Sites exhibiting > or =2 mm of attachment loss in 2 successive or alternate evaluations, and periodontal abscess were noticed only in the placebo group. CONCLUSIONS: A 1-week course of systemic M+A every 4 months, as the only therapy, arrests the progression of adult periodontitis and significantly improves the clinical parameters of the disease.
Authors: Raluca Cosgarea; Christian Heumann; Raluca Juncar; Roxana Tristiu; Liana Lascu; Giovanni E Salvi; Nicole B Arweiler; Anton Sculean Journal: PLoS One Date: 2017-06-29 Impact factor: 3.240