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metronidazole therapy may improve the effectiveness of scaling and root planing in patients with periodontitis
RESEARCH
CRITICAL
SUMMARIES
Amoxicillin/metronidazole therapy may improve the effectiveness of scaling and root planing in patients with periodontitis L. Virginia Powell, DMD
Chronic periodontitis A critical summary of Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis (published online ahead of print Feb. 14, 2012). J Periodontol 2012;83(10):1257-1269. doi:10.1902/jop.2012.110625. Systematic review conclusion. Preliminary evidence suggests scaling and root planing (SRP) in combination with amoxicillin (AMX)/metronidazole (MET) (SRP + AMX/MET) therapy may be more effective in treating chronic periodontitis (CP) than is SRP alone. Critical summary assessment. Preliminary evidence from a meta-analysis of four randomized clinical trials (RCTs) seems to support the effectiveness of systemic AMX/MET therapy as an adjunct to SRP alone in treating CP, although safety data are incomplete. Evidence quality rating. Limited.
Clinical question. What are the effectiveness and safety of com- bined AMX/MET therapy as an adjunct to SRP compared with those of SRP alone in the treatment of adult patients with CP? Review methods. Using a well-developed search strategy, two reviewers searched multiple databases for articles published through Oct. 8, 2011. They also conducted a manual search of se- lected journals published during the preceding 15 years. They hand searched reference lists of selected full-text articles and reviews and included articles in all languages. Inclusion criteria included RCTs with a parallel design, studies in which investigators compared SRP with SRP + AMX/MET therapy and
studies involving adults (> 18 years) with CP. The reviewers excluded studies in which investigators did not measure clinical attachment level (CAL) and full-mouth probing depth (PD), that included patients with systemic disease or those who took medications known to affect periodontal tissues within the preceding six months, or that had a follow-up of less than three months or were duplicates. The two reviewers screened articles independently and resolved discrepancies by means of discussion. They combined data for meta-analysis, evaluated heterogeneity and estimated risk of bias. Main results. The reviewers selected four RCTs, which included a total of 147 patients, for analy-
sis. Two of these RCTs had a low risk of bias. Patients in the SRP + AMX/MET therapy group demonstrated a greater gain in CAL compared with patients in the SRP group (mean difference [MD], 0.21 millimeters; 95 percent confidence interval [CI], 0.02-0.40; P < .05) and a greater reduction in PD (MD, 0.43 mm; 95 percent CI, 0.240.63; P < .05). The reviewers found no significant differences between groups with regard to bleeding on probing or suppuration. They did not analyze microbial differences, compliance or adverse events. Heterogeneity was not significant for the analysis of CAL and PD. Funnel plots were symmetrical for primary outcomes. Conclusions. Systemic AMX/ MET may provide additional ben- efits to SRP in the treatment of CP in terms of CAL gain and PD reduction. The results, however, were based on a small number of studies and should be considered preliminary. No sources of funding for this systematic review were listed.
640 JADA 144(6) http://jada.ada.org June 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
RESEARCH
COMMENTARY
Importance and context. A professional organiza tion has advocated for the use of antibiotics as an adjunct to SRP therapy, especially in refractory cases in which there has been little or no response to SRP alone.1 Because practitioners are cautioned to use antibiotics sparingly to avoid antibiotic resistance and adverse events, the added benefit of antibiotics needs to be identified so that appropriate protocols may be developed. Strengths and weaknesses of the system- atic review. The reviewers designed a thorough and inclusive search strategy and established a priori inclusion and exclusion criteria. Two reviewers determined which studies met the inclu- sion criteria and reconciled any disagreements. They evaluated the studies for risk of bias and heterogeneity. They displayed demographic data in table format and retrieved information from study authors if it was not available in the pub- lished article. They presented the meta-analysis in forest plots and evaluated publication bias by means of a funnel plot.
CRITICAL
SUMMARIES
Strengths and weaknesses of the evidence. The total number of RCTs was small (n = 4), and the number of participants was small (n = 147). Only two of the trials were considered to have a low risk of bias. Studies were similar in design, as demonstrated by the lack of heterogeneity for the primary outcomes, but dosing regimens were different. Time frames were variable (three-24 months). The primary outcome variables were standardized, but the collection of compliance and adverse events data was not, thus no conclusions could be made in regard to these secondary variables. Implications for dental practice. Although preliminary evidence suggests that the addition of systemic AMX/MET to SRP for patients with CP may improve treatment effects, optimum treatment regimens have yet to be developed, and adverse events may affect compliance. Therefore, the routine use of AMX/MET cannot be recommended at this time. 1. Slots J; Research, Science and Therapy Committee of the American Academy of Periodontology. Systemic antibiotics in periodontics. J Periodontol 2004;75(11):1553-1565.
Aggressive periodontitis A critical summary of Sgolastra F, Petrucci A, Gatto R, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as an adjunctive therapy to full-mouth scaling and root planing in the treatment of aggressive periodontitis: a systematic review and meta-analysis (published online ahead of print Nov. 3, 2011). J Periodontol 2012;83(6):731-743. doi:10.1902/ jop.2011.110432. Systematic review conclusion. Full-mouth scaling and root planing (FMSRP) in combination with amoxicillin (AMX)/metronidazole (MET) (FMSRP + AMX/MET) therapy is more effective in treating generalized aggressive periodontitis (GAgP) than is FMSRP alone. Critical summary assessment. The results of a meta-analysis of six randomized clinical trials (RCTs) of high quality support the use of AMX/MET therapy to increase the effectiveness of FMSRP in treating GAgP. Evidence quality rating. Good.
Clinical question. What are the effectiveness and safety of combined AMX/MET therapy as an adjunct to FMSRP when compared with those of FMSRP alone in the treatment of adult patients with GAgP? Review methods. Two reviewers searched multiple databases by using a well-developed search strategy for articles pub-
lished through Sept. 11, 2011. They also conducted a manual search of selected journals published during the preceding 15 years. They hand searched reference lists of selected full-text articles and reviews and included articles in all languages. Eligibility criteria included RCTs, studies in which investigators compared FMSRP with FMSRP + AMX/MET therapy and studies
involving adults (> 18 years) with GAgP. They screened studies meeting these criteria further for the following exclusion criteria: studies in which investigators included patients with systemic disease or taking antibiotics or medications known to affect periodontal tissues, had a follow-up of less than two months, were duplicate studies, and did not measure clinical attachment level (CAL) and fullmouth probing depth (PD). The two reviewers screened articles independently and resolved discrepancies by means of discussion. The reviewers evaluated heterogeneity and estimated risk of bias. They used a random-effects model to conduct their meta-analysis. Main results. The reviewers
JADA 144(6) http://jada.ada.org June 2013 641 Copyright © 2013 American Dental Association. All Rights Reserved.
RESEARCH
CRITICAL
SUMMARIES
selected six RCTs, which included a total of 181 patients, for analysis. Five of the RCTs had a low risk of bias. Patients in the FMSRP + AMX/MET therapy group demonstrated an increased gain in CAL compared with that in patients in the FMSRP group (mean difference [MD], 0.42 millimeters; 95 percent confidence interval [CI], 0.23-0.61; P < .05) and an increased reduction in PD (MD, 0.58 mm; 95 percent
CI, 0.39-0.77; P < .05). Patients in the FMSRP + AMX/MET group also had improved scores for bleeding on probing and gingival bleeding. Differences in visible plaque and adverse events were not clinically significant, although adverse events (for example, diarrhea and vomiting) were given as the main reason for noncompliance with the antibiotic therapy. No serious adverse events were reported.
COMMENTARY
Importance and context. A professional or- ganization has advocated that antibiotics be used as an adjunct to SRP therapy, especially in refractory cases in which there has been little or no response to SRP alone.1 Because practitioners are cautioned to use antibiotics sparingly to avoid antibiotic resistance and adverse events, the added benefit of antibiotics needs to be identified so that appropriate protocols may be developed. Strengths and weaknesses of the systematic review. The reviewers designed a thorough and inclusive search strategy and established a priori inclusion and exclusion criteria. Two reviewers determined which studies met the inclusion criteria and reconciled any disagreements. The reviewers evaluated studies for risk of bias and heterogeneity. They displayed demographic data in table format and retrieved information from study authors if it was not available in the published article. They presented the metaanalysis in forest plots and evaluated publication bias with a funnel plot. Strengths and weaknesses of the evidence. The total number of RCTs was small (n = 6), and the total number of participants was small (n = 181). The RCTs, however, were of relatively high quality. The studies were similar in design as demonstrated by the lack of heterogeneity for the primary outcomes, but dosing regimens were different. Study design appeared to mitigate the effects of strong confounding variables such as smoking. Although the mean CAL and PD changes seemed small, this result is
Heterogeneity was not significant for the analysis of CAL and PD. Funnel plots were symmetrical for primary outcomes. Conclusions. AMX/MET provide additional benefits over FMSRP alone in the treatment of GAgP in terms of CAL gain and PD reduction. No sources of funding for this systematic review were listed.
typical when full-mouth measurements are averaged. Furthermore, the results would be generalizable to populations with GAgP. Time frames were short (two-six months), and although the primary outcome variables were standardized, the collection of compliance and adverse event data was not. Gastrointestinal adverse effects, the most serious of the reported adverse events, may be understated owing to lack of power in the subgroup analysis. Implications for dental practice. Dentists may improve the treatment effects of FMSRP with the addition of AMX/MET for patients with GAgP, although optimum treatment regimens have yet to be developed and adverse events, especially gastrointestinal, may affect compliance. n 1. Slots J; Research, Science and Therapy Committee of the American Academy of Periodontology. Systemic antibiotics in periodontics. J Periodontol 2004;75(11):1553-1565. Dr. Powell maintains a private practice in Ukiah, Calif. She also is an evidence reviewer for the American Dental Association. Address reprint requests to Dr. Powell at 1091 S. Dora St., Ukiah, Calif. 95482, e-mail [email protected]. Disclosure. Dr. Powell did not report any disclosures. These summaries, published under the auspices of the American Dental Association Center for Evidence-Based Dentistry, are prepared by practitioners trained in critical appraisal of published systematic reviews who work under the mentorship of experts. The summaries are not intended to, and do not, express, imply or summarize standards of care, but rather provide a concise reference for dentists to aid in understanding and applying evidence from the referenced systematic review in making clinically sound decisions as guided by their clinical judgment and by patient needs. For more information on the evidence quality rating provided above and additional critical summaries, please visit http://ebd.ada.org.
642 JADA 144(6) http://jada.ada.org June 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
CRITICAL
SUMMARIES
Amoxicillin/metronidazole therapy may improve the effectiveness of scaling and root planing in patients with periodontitis L. Virginia Powell, DMD
Chronic periodontitis A critical summary of Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis (published online ahead of print Feb. 14, 2012). J Periodontol 2012;83(10):1257-1269. doi:10.1902/jop.2012.110625. Systematic review conclusion. Preliminary evidence suggests scaling and root planing (SRP) in combination with amoxicillin (AMX)/metronidazole (MET) (SRP + AMX/MET) therapy may be more effective in treating chronic periodontitis (CP) than is SRP alone. Critical summary assessment. Preliminary evidence from a meta-analysis of four randomized clinical trials (RCTs) seems to support the effectiveness of systemic AMX/MET therapy as an adjunct to SRP alone in treating CP, although safety data are incomplete. Evidence quality rating. Limited.
Clinical question. What are the effectiveness and safety of com- bined AMX/MET therapy as an adjunct to SRP compared with those of SRP alone in the treatment of adult patients with CP? Review methods. Using a well-developed search strategy, two reviewers searched multiple databases for articles published through Oct. 8, 2011. They also conducted a manual search of se- lected journals published during the preceding 15 years. They hand searched reference lists of selected full-text articles and reviews and included articles in all languages. Inclusion criteria included RCTs with a parallel design, studies in which investigators compared SRP with SRP + AMX/MET therapy and
studies involving adults (> 18 years) with CP. The reviewers excluded studies in which investigators did not measure clinical attachment level (CAL) and full-mouth probing depth (PD), that included patients with systemic disease or those who took medications known to affect periodontal tissues within the preceding six months, or that had a follow-up of less than three months or were duplicates. The two reviewers screened articles independently and resolved discrepancies by means of discussion. They combined data for meta-analysis, evaluated heterogeneity and estimated risk of bias. Main results. The reviewers selected four RCTs, which included a total of 147 patients, for analy-
sis. Two of these RCTs had a low risk of bias. Patients in the SRP + AMX/MET therapy group demonstrated a greater gain in CAL compared with patients in the SRP group (mean difference [MD], 0.21 millimeters; 95 percent confidence interval [CI], 0.02-0.40; P < .05) and a greater reduction in PD (MD, 0.43 mm; 95 percent CI, 0.240.63; P < .05). The reviewers found no significant differences between groups with regard to bleeding on probing or suppuration. They did not analyze microbial differences, compliance or adverse events. Heterogeneity was not significant for the analysis of CAL and PD. Funnel plots were symmetrical for primary outcomes. Conclusions. Systemic AMX/ MET may provide additional ben- efits to SRP in the treatment of CP in terms of CAL gain and PD reduction. The results, however, were based on a small number of studies and should be considered preliminary. No sources of funding for this systematic review were listed.
640 JADA 144(6) http://jada.ada.org June 2013 Copyright © 2013 American Dental Association. All Rights Reserved.
RESEARCH
COMMENTARY
Importance and context. A professional organiza tion has advocated for the use of antibiotics as an adjunct to SRP therapy, especially in refractory cases in which there has been little or no response to SRP alone.1 Because practitioners are cautioned to use antibiotics sparingly to avoid antibiotic resistance and adverse events, the added benefit of antibiotics needs to be identified so that appropriate protocols may be developed. Strengths and weaknesses of the system- atic review. The reviewers designed a thorough and inclusive search strategy and established a priori inclusion and exclusion criteria. Two reviewers determined which studies met the inclu- sion criteria and reconciled any disagreements. They evaluated the studies for risk of bias and heterogeneity. They displayed demographic data in table format and retrieved information from study authors if it was not available in the pub- lished article. They presented the meta-analysis in forest plots and evaluated publication bias by means of a funnel plot.
CRITICAL
SUMMARIES
Strengths and weaknesses of the evidence. The total number of RCTs was small (n = 4), and the number of participants was small (n = 147). Only two of the trials were considered to have a low risk of bias. Studies were similar in design, as demonstrated by the lack of heterogeneity for the primary outcomes, but dosing regimens were different. Time frames were variable (three-24 months). The primary outcome variables were standardized, but the collection of compliance and adverse events data was not, thus no conclusions could be made in regard to these secondary variables. Implications for dental practice. Although preliminary evidence suggests that the addition of systemic AMX/MET to SRP for patients with CP may improve treatment effects, optimum treatment regimens have yet to be developed, and adverse events may affect compliance. Therefore, the routine use of AMX/MET cannot be recommended at this time. 1. Slots J; Research, Science and Therapy Committee of the American Academy of Periodontology. Systemic antibiotics in periodontics. J Periodontol 2004;75(11):1553-1565.
Aggressive periodontitis A critical summary of Sgolastra F, Petrucci A, Gatto R, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as an adjunctive therapy to full-mouth scaling and root planing in the treatment of aggressive periodontitis: a systematic review and meta-analysis (published online ahead of print Nov. 3, 2011). J Periodontol 2012;83(6):731-743. doi:10.1902/ jop.2011.110432. Systematic review conclusion. Full-mouth scaling and root planing (FMSRP) in combination with amoxicillin (AMX)/metronidazole (MET) (FMSRP + AMX/MET) therapy is more effective in treating generalized aggressive periodontitis (GAgP) than is FMSRP alone. Critical summary assessment. The results of a meta-analysis of six randomized clinical trials (RCTs) of high quality support the use of AMX/MET therapy to increase the effectiveness of FMSRP in treating GAgP. Evidence quality rating. Good.
Clinical question. What are the effectiveness and safety of combined AMX/MET therapy as an adjunct to FMSRP when compared with those of FMSRP alone in the treatment of adult patients with GAgP? Review methods. Two reviewers searched multiple databases by using a well-developed search strategy for articles pub-
lished through Sept. 11, 2011. They also conducted a manual search of selected journals published during the preceding 15 years. They hand searched reference lists of selected full-text articles and reviews and included articles in all languages. Eligibility criteria included RCTs, studies in which investigators compared FMSRP with FMSRP + AMX/MET therapy and studies
involving adults (> 18 years) with GAgP. They screened studies meeting these criteria further for the following exclusion criteria: studies in which investigators included patients with systemic disease or taking antibiotics or medications known to affect periodontal tissues, had a follow-up of less than two months, were duplicate studies, and did not measure clinical attachment level (CAL) and fullmouth probing depth (PD). The two reviewers screened articles independently and resolved discrepancies by means of discussion. The reviewers evaluated heterogeneity and estimated risk of bias. They used a random-effects model to conduct their meta-analysis. Main results. The reviewers
JADA 144(6) http://jada.ada.org June 2013 641 Copyright © 2013 American Dental Association. All Rights Reserved.
RESEARCH
CRITICAL
SUMMARIES
selected six RCTs, which included a total of 181 patients, for analysis. Five of the RCTs had a low risk of bias. Patients in the FMSRP + AMX/MET therapy group demonstrated an increased gain in CAL compared with that in patients in the FMSRP group (mean difference [MD], 0.42 millimeters; 95 percent confidence interval [CI], 0.23-0.61; P < .05) and an increased reduction in PD (MD, 0.58 mm; 95 percent
CI, 0.39-0.77; P < .05). Patients in the FMSRP + AMX/MET group also had improved scores for bleeding on probing and gingival bleeding. Differences in visible plaque and adverse events were not clinically significant, although adverse events (for example, diarrhea and vomiting) were given as the main reason for noncompliance with the antibiotic therapy. No serious adverse events were reported.
COMMENTARY
Importance and context. A professional or- ganization has advocated that antibiotics be used as an adjunct to SRP therapy, especially in refractory cases in which there has been little or no response to SRP alone.1 Because practitioners are cautioned to use antibiotics sparingly to avoid antibiotic resistance and adverse events, the added benefit of antibiotics needs to be identified so that appropriate protocols may be developed. Strengths and weaknesses of the systematic review. The reviewers designed a thorough and inclusive search strategy and established a priori inclusion and exclusion criteria. Two reviewers determined which studies met the inclusion criteria and reconciled any disagreements. The reviewers evaluated studies for risk of bias and heterogeneity. They displayed demographic data in table format and retrieved information from study authors if it was not available in the published article. They presented the metaanalysis in forest plots and evaluated publication bias with a funnel plot. Strengths and weaknesses of the evidence. The total number of RCTs was small (n = 6), and the total number of participants was small (n = 181). The RCTs, however, were of relatively high quality. The studies were similar in design as demonstrated by the lack of heterogeneity for the primary outcomes, but dosing regimens were different. Study design appeared to mitigate the effects of strong confounding variables such as smoking. Although the mean CAL and PD changes seemed small, this result is
Heterogeneity was not significant for the analysis of CAL and PD. Funnel plots were symmetrical for primary outcomes. Conclusions. AMX/MET provide additional benefits over FMSRP alone in the treatment of GAgP in terms of CAL gain and PD reduction. No sources of funding for this systematic review were listed.
typical when full-mouth measurements are averaged. Furthermore, the results would be generalizable to populations with GAgP. Time frames were short (two-six months), and although the primary outcome variables were standardized, the collection of compliance and adverse event data was not. Gastrointestinal adverse effects, the most serious of the reported adverse events, may be understated owing to lack of power in the subgroup analysis. Implications for dental practice. Dentists may improve the treatment effects of FMSRP with the addition of AMX/MET for patients with GAgP, although optimum treatment regimens have yet to be developed and adverse events, especially gastrointestinal, may affect compliance. n 1. Slots J; Research, Science and Therapy Committee of the American Academy of Periodontology. Systemic antibiotics in periodontics. J Periodontol 2004;75(11):1553-1565. Dr. Powell maintains a private practice in Ukiah, Calif. She also is an evidence reviewer for the American Dental Association. Address reprint requests to Dr. Powell at 1091 S. Dora St., Ukiah, Calif. 95482, e-mail [email protected]. Disclosure. Dr. Powell did not report any disclosures. These summaries, published under the auspices of the American Dental Association Center for Evidence-Based Dentistry, are prepared by practitioners trained in critical appraisal of published systematic reviews who work under the mentorship of experts. The summaries are not intended to, and do not, express, imply or summarize standards of care, but rather provide a concise reference for dentists to aid in understanding and applying evidence from the referenced systematic review in making clinically sound decisions as guided by their clinical judgment and by patient needs. For more information on the evidence quality rating provided above and additional critical summaries, please visit http://ebd.ada.org.
642 JADA 144(6) http://jada.ada.org June 2013 Copyright © 2013 American Dental Association. All Rights Reserved.