Dataset Information

One year results of a randomized controlled clinical study evaluating the effects of non-surgical periodontal therapy of chronic periodontitis in conjunction with three or seven days systemic administration of amoxicillin/metronidazole.

ABSTRACT:

Background

To evaluate the clinical outcomes 12 months after systemic administration of amoxicillin (AMX) and metronidazole (MET) adjunctive to subgingival debridement (SD) in patients with severe chronic periodontitis (sChP).

Material and methods

102 patients with sChP were treated randomly as follows: SD within 2 consecutive days and placebo for 7 days (group A), SD+AMX+MET (both 500mg x3 times daily TID) for 3 days (group B), SD+AMX+MET (both 500mg x 3 TID) for 7 days (group C). At baseline, at 3-, 6-, and 12-months post-treatment probing pocket depth (PD), clinical attachment level (CAL), furcation involvement, bleeding on probing (BOP), full-mouth plaque score (FMPS) were determined. The reduction in the number of sites with PD?6mm was defined as main outcome variable.

Results

75 patients completed the study. At 12 months, all three treatment groups showed statistically significant improvements (p<0.001) of mean PD, CAL, BOP and number of sites with PD?6mm compared to baseline. Mean residual PD were statistically significantly lower and CAL gain statistically significantly greater in the two antibiotic groups as compared to placebo. While PD reductions (p = 0.012) and CAL gain (p = 0.017) were statistically significantly higher in group C compared to group A, only the 3-day AB group showed statistically significantly fewer sites with PD?6mm at 12 m (p = 0.003). The reduction in the number of sites with PD?6 mm (primary outcome) showed no statistical significant differences between the 3 treatment groups. However, in both antibiotic groups significantly more patients compared to the placebo group reached a low risk for disease progression at 12 months (?4 sites with PD?5mm).

Conclusion

At 12 months, both adjunctive antibiotic protocols resulted in statistically significantly greater clinical improvements compared to placebo.

SUBMITTER: Cosgarea R

PROVIDER: S-EPMC5491014 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

One year results of a randomized controlled clinical study evaluating the effects of non-surgical periodontal therapy of chronic periodontitis in conjunction with three or seven days systemic administration of amoxicillin/metronidazole.

Cosgarea Raluca R Heumann Christian C Juncar Raluca R Tristiu Roxana R Lascu Liana L Salvi Giovanni E GE Arweiler Nicole B NB Sculean Anton A

PloS one 20170629 6

<h4>Background</h4>To evaluate the clinical outcomes 12 months after systemic administration of amoxicillin (AMX) and metronidazole (MET) adjunctive to subgingival debridement (SD) in patients with severe chronic periodontitis (sChP).<h4>Material and methods</h4>102 patients with sChP were treated randomly as follows: SD within 2 consecutive days and placebo for 7 days (group A), SD+AMX+MET (both 500mg x3 times daily TID) for 3 days (group B), SD+AMX+MET (both 500mg x 3 TID) for 7 days (group C) ...[more]

PMID: 28662049

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Project description:BACKGROUND:The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) with scaling and root planing (SRP) has shown to be an effective periodontal treatment. However, some essential issues associated with the use of these antibiotics remain unanswered, such as the ideal time of administration during the course of periodontal treatment. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this RCT is to compare the clinical, microbiological and immunological effects of the adjunctive systemic MTZ + AMX administered in different phases of the treatment of severe periodontitis. METHODS:Subjects with severe periodontitis (n = 180) are being randomly assigned into three groups (n = 60/group): (i) SRP-only (control group), SRP in combination with 400 mg MTZ + 500 mg AMX, starting (ii) at the first SRP session (active phase group), or (iii) after 3 months of its completion (healing phase group). All volunteers are receiving clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment at baseline and 12 months post-therapy. Nine subgingival biofilm samples are being collected per subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization, and six gingival crevicular fluid samples are being collected and analyzed for the levels of 20 chemokines by multiplex immunoassay. The primary outcome variable is the number of volunteers reaching the clinical endpoint for treatment (??4 sites with probing depth ?5 mm) at 1 year post-therapy. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using analysis of variance, analysis of covariance and the Chi-square and Tukey tests. Microbiological and immunological analyses will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%. TRIAL REGISTRATION:ClinicalTrials.gov , NCT02954393 . Registered on 3 November 2016.

Project description:The aim of this follow-up study was, to compare the effects of mechanical periodontal therapy with or without adjunctive amoxicillin and metronidazole on the subgingival microbiome of smokers with periodontitis using 16S rDNA amplicon next generation sequencing. Fifty-four periodontitis patients that smoke received either non-surgical periodontal therapy with adjunctive amoxicillin and metronidazole (n = 27) or with placebos (n = 27). Subgingival plaque samples were taken before and two months after therapy. Bacterial genomic DNA was isolated and the V4 hypervariable region of the bacterial 16S rRNA genes was amplified. Up to 96 libraries were normalized and pooled for Illumina MiSeq paired-end sequencing with almost fully overlapping 250 base pairs reads. Exact ribosomal sequence variants (RSVs) were inferred with DADA2. Microbial diversity and changes on the genus and RSV level were analyzed with non-parametric tests and a negative binomial regression model, respectively. Before therapy, the demographic, clinical, and microbial parameters were not significantly different between the placebo and antibiotic groups. Two months after the therapy, clinical parameters improved and there was a significantly increased dissimilarity of microbiomes between the two groups. In the antibiotic group, there was a significant reduction of genera classified as Porphyromonas, Tannerella, and Treponema, and 22 other genera also decreased significantly, while Selenomonas, Capnocytophaga, Actinomycetes, and five other genera significantly increased. In the placebo group, however, there was not a significant decrease in periodontal pathogens after therapy and only five other genera decreased, while Veillonella and nine other genera increased. We conclude that in periodontitis patients who smoke, microbial shifts occurred two months after periodontal therapy with either antibiotics or placebo, but genera including periodontal pathogens decreased significantly only with adjunctive antibiotics.

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Dataset Information

One year results of a randomized controlled clinical study evaluating the effects of non-surgical periodontal therapy of chronic periodontitis in conjunction with three or seven days systemic administration of amoxicillin/metronidazole.

Background

Material and methods

Results

Conclusion

Publications

One year results of a randomized controlled clinical study evaluating the effects of non-surgical periodontal therapy of chronic periodontitis in conjunction with three or seven days systemic administration of amoxicillin/metronidazole.

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