ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Inconsistent Evidence Supports Adjunctive Use of Systemic Metronidazole in Chronic Periodontitis
Clinical Question In adults with chronic periodontitis, does systemic metronidazole given in conjunction to conventional non-surgical mechanical periodontal therapy reduce periodontal pocket depth more than placebo in conjunction to conventional non-surgical mechanical periodontal therapy?
Clinical Bottom Line There is currently no evidence to so suggest that metronidazole alongside conventional mechanical treatment produces a greater reduction in pocket depth compared to conventional therapy alone. Pocket depth reduction is the most quantifiable way to evaluate the success or failure of instrumentation.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 15311314Vergani/200412 patients with chronic periodontitis (aged 29-63) divided into 3 groups: Group 1 had S&RP alone, Group 2 had S&RP and 250mg metronidazole TDS for 10 days and Group 3 had metronidazole alone. Randomized Controlled Trial
Key resultsGroup 1 had scaling and root planing, group 2 had scaling and root planing and 250mg of metronidazole (TDS for 10 days) and group 3 had 250mg of metronidazole (TDS for 10 days) only. Regarding clinical outcomes, statistical differences were observed only for the gingival index (p = 0.0261) between Groups I and 2, and probing depth (p = 0.0124) between Group 1 and the other groups. These differences were observed at 30, 60 and 90 days after baseline. It was concluded that the use of systemic metronidazole did not produce additional effects on the microbiological conditions of these patients with chronic periodontal disease. Overall, the use of metronidazole in patients with chronic periodontitis seems to be unjustified.
#2) 23016867Feres/2012118 subjects with chronic periodontitis (aged 30 and over) divided into 3 groups: Group 1 had S&RP alone, Group 2 had S&RP and metronidazole 400mg TDS for 14 days and Group 3 had SR&P and metronidazole and amoxicillin 500mg TDS for 14 days. Randomized Controlled Trial
Key resultsControl group had scaling and root planing and there were two antibiotic groups alongside scaling and root planing (metronidazole, MTZ, 400mg TDS for 14 days and MTZ and Amoxicillin, AMX, 500mg TDS for 14 days). The two antibiotic groups had a statistically greater reduction in probing depth and gain in clinical attachments than those in the control group at all-time points (3, 6 and 12 month) in initially intermediate and deep sites. They also had significantly fewer sites with probing depth ≥5mm, ≥6mm, ≥7mm and ≥8mm compared with the control group. The data of this study suggested that the adjunctive use of MTZ or MTZ & AMX in the treatment of subjects with chronic periodontitis improves the clinical outcomes of scaling and root planing therapy.
#3) 21762197Silva/201151 subjects with generalised chronic periodontitis (aged 30 and over) divided into 3 Groups: Group 1 had S&RP alone, Group 2 had S&RP and metronidazole 400mg TDS for 14 days and Group 3 had SR&P and metronidazole and amoxicillin 400mg BDS for 14 daysRandomized Controlled Trial
Key resultsControl group had scaling and root planing and there were two antibiotic groups alongside scaling and root planing (metronidazole, MTZ, 400mg BDS for 14 days and MTZ and Amoxicillin, AMX, 500mg BDS for 14 days). The mean clinical attachment gain (mm) in pocket depths ≥7mm were 2.09 ± 1.03 for the control group and 2.67 ± 1.30 for SRP+MTZ: and 2.97 ± 0.67 for SRP+MTZ+AMX (P=0.032). Both antibiotic treatments elicited a statistically greater reduction in the mean full-mouth pocket depth than scaling and root planing alone. Post-therapy, the control group had 13.3±14.9 residual deep sites compared to 9.4±8.8 for MRZ and 5.3±4.4 for MTZ+AMZ. The adjunctive use of MTZ+AMX offers short-term clinical and microbiological benefits, over SRP alone, in the treatment of subjects with generalised chronic periodontitis. Metronidazole alone also led to additional benefits, although less evident.
Evidence Search EBM Reviews (Cochrane database of systematic reviews and Cochrane register of controlled trials), Medline (Ovid) and EMBASE (Ovid) and hand search of Journal of Periodontology, Journal of Clinical Periodontology and relevant bibliographies. [1 results from both EBM reviews - not relevant, 38 results from Medline - 4 relevant, 58 results from EMBASE- 1 relevant, 413 results from Journal of Periodontology and Clinical Periodontology - 6 relevant, Bibliographies search - 2 relevant. These 13 relevant articles were reduced to 3 by using an appropriate inclusion criteria.
Comments on
The Evidence
All three papers are randomised controlled trials (RCTs) and are considered to have the highest level of evidence. Random allocation ensures no systematic differences between intervention groups in factors, known and unknown, that may affect the outcome. Feres et al. (2012) and Silva et al. (2011) are both double-blind and placebo-controlled trials. They are regarded as the gold standard for clinical research. Vergani et al. (2004) is a single-blind study as the patients were not blind as to which treatment group they were in. This may lead to a change in behaviour of the subjects, and potentially changing the results of the study. Although RCTs are powerful tools, their use is limited by ethical concerns (Sibbald & Roland, 1988). However, all three studies had their study protocol approved by a Brazilian Ethics Committee. In light of this, the participants are assumed to have a Brazilian origin and therefore, may not give a true representation of the general public. It is, therefore, wrong to suggest that the results found in these studies are valid for all populations. Eliminating funding bias is another way to prevent predetermined conclusions. All three papers include how their study was funded and all benefactors would not have a vested interest in the study outcomes. Silva et al. (2011) does not include how some of the study was funded, reducing validity. However, both Feres et al. (2012) and Silva et al. (2011) both state that the authors declared no conflict of interests. Feres et al. (2012) and Silva et al. (2011) established the ideal sample size to assure adequate power. Performing power analysis and sample size estimation implements precision. If a sample size is too low, as perhaps in Vergani et al. (2004) (12 subjects in total), the experiment will lack the precision for reliable results. All three studies are strong as concealment of treatment allocation is ascertained. Vergani et al. (2004) did not specify their methodology for this. Feres et al. (2012) and Silva et al. (2011) gave each subject a code and the study coordinators used a computer-generated table to allocate them to a treatment group. Potential bias is reduced with such concealment. In addition, all study personnel, were blinded to treatment assignment – this confers the strength of the ‘double-blind’ aspect of these two studies. The control group for all three studies was ‘scaling and root planing procedures’ (SRP). The methodology for this was not included in Vergani et al. (2004) unlike in Feres et al. (2012) and Silva et al. (2011). Both studies had two trained periodontists perform SRP in a specific time frame and the procedure was outlined in very similar ways. They both deciphered an end-point for each SRP appointment, which was checked by a study coordinator. This suggests that the results are more accurate and, as SRP is technique sensitive, are more reproducible. The two periodontists were randomised according to the different treatments so that each treated the same number of patients in each group. This minimised any potential selection bias. Vervain et al. 2004 suggests that the use of metronidazole in managing chronic periodontitis is unjustified. However, Feres et al. 2012 and Silva et al. 2011 have very similar thorough methodologies and confer a high level of evidence and superiority of the antibiotic (both metronidazole and metronidazole and amoxicillin) regimes. The additional benefits of metronidazole was seen in the clinical parameter rather than microbiological outcomes, but not necessarily statistically significant.
Applicability The suggestion of adjunctive metronidazole during the first round of SR&P is not unreasonable as it saves both time and money in the long-run, but there are questions regarding antibiotic resistance and the potential adverse effects. There are currently no set guidelines regarding the specific selection and administration of an appropriate antibiotic regimen in conjunction with conventional periodontal therapy. The current literature do not unanimously agree regarding implications of adjunctive systemic metronidazole in practice for treating chronic periodontitis. Therefore, more information is needed to suggest the use of metronidazole in the treatment for chronic periodontitis.
Specialty/Discipline (Periodontics)
Keywords systemic metronidazole, chronic periodontitis, pocket depth, scaling, debridement, root planing
ID# 2981
Date of submission: 03/15/2016spacer
E-mail kate.mckenzie@manchester.ac.uk
Author Kate McKenzie, University of Manchester
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