Journal of periodontology · 2010
Efficacy and safety of adjunctive local moxifloxacin delivery in the treatment of periodontitis.
Клиническое исследование II фазыСравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Flemmig Thomas F, Petersilka Gregor, Völp Andreas, Gravemeier Martina, Zilly Martin, Mross Daniela, Prior Karola, Yamamoto Julie, Beikler Thomas
Аннотация
BACKGROUND: Moxifloxacin exerts excellent antibacterial activity against most putative periodontal pathogens and has been shown to kill bacteria in biofilm and host cells.
METHODS: Patients with chronic periodontitis were randomly assigned to receive a single subgingival application of a 0.125%, 0.4%, or 1.25% moxifloxacin gel or placebo gel immediately after full-mouth scaling and root planing (SRP). Clinical efficacy measurements were assessed in sites with baseline probing depth (PD) of ≥5.4 mm at 6 weeks and 3 months and any adverse events were determined. In addition, putative periodontal pathogens and resistance of subgingival bacteria against moxifloxacin were assessed.
RESULTS: Data of 57 patients were included in the statistical analysis. In all treatment groups, the PD decreased from baseline to 3 months, with the greatest reduction seen in patients treated with moxifloxacin 0.4% (1.5 ± 0.6 mm; P = 0.023 compared to placebo), followed by patients receiving moxifloxacin 1.25% (1.2 ± 0.4), moxifloxacin 0.125% (1.1 ± 1.1), and placebo (1.0 ± 0.6). No linear trend for PD reduction with increasing moxifloxacin concentrations was found. Porphyromonas gingivalis showed the greatest reduction in prevalence among the assessed pathogens, without any significant intergroup differences. No correlation or systematic relationship between adverse events, including bacterial resistance against moxifloxacin, and the investigational gels was found.
CONCLUSIONS: In periodontal pockets with PD of ≥5.4 mm, a single subgingival administration of a 0.4% moxifloxacin gel as an adjunct to SRP may result in additional PD reduction compared to SRP alone. In addition, the investigated moxifloxacin gels seem to be safe.
METHODS: Patients with chronic periodontitis were randomly assigned to receive a single subgingival application of a 0.125%, 0.4%, or 1.25% moxifloxacin gel or placebo gel immediately after full-mouth scaling and root planing (SRP). Clinical efficacy measurements were assessed in sites with baseline probing depth (PD) of ≥5.4 mm at 6 weeks and 3 months and any adverse events were determined. In addition, putative periodontal pathogens and resistance of subgingival bacteria against moxifloxacin were assessed.
RESULTS: Data of 57 patients were included in the statistical analysis. In all treatment groups, the PD decreased from baseline to 3 months, with the greatest reduction seen in patients treated with moxifloxacin 0.4% (1.5 ± 0.6 mm; P = 0.023 compared to placebo), followed by patients receiving moxifloxacin 1.25% (1.2 ± 0.4), moxifloxacin 0.125% (1.1 ± 1.1), and placebo (1.0 ± 0.6). No linear trend for PD reduction with increasing moxifloxacin concentrations was found. Porphyromonas gingivalis showed the greatest reduction in prevalence among the assessed pathogens, without any significant intergroup differences. No correlation or systematic relationship between adverse events, including bacterial resistance against moxifloxacin, and the investigational gels was found.
CONCLUSIONS: In periodontal pockets with PD of ≥5.4 mm, a single subgingival administration of a 0.4% moxifloxacin gel as an adjunct to SRP may result in additional PD reduction compared to SRP alone. In addition, the investigated moxifloxacin gels seem to be safe.
Предметные рубрики MeSH
Administration, TopicalAdultAgedAggregatibacter actinomycetemcomitansAnti-Infective AgentsAza CompoundsBacterial LoadBacteroidesChronic PeriodontitisDental PlaqueDental ScalingDrug Resistance, BacterialFemaleFluoroquinolonesFollow-Up StudiesGingival HemorrhageGingival RecessionHumansMaleMiddle AgedMoxifloxacinPeriodontal Attachment LossPeriodontal PocketPlacebosPorphyromonas gingivalisQuinolinesRoot PlaningSafetyStreptococcus intermediusTreatment OutcomeTreponema denticola