Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease

Philip M. Preshaw, M. John Novak, James Mellonig, Ingvar Magnusson, Alan Polson, William V. Giannobile, Randal W. Rowland, John Thomas, Clay Walker, Dolphus R. Dawson, Dennis Sharkey, Mark H. Bradshaw

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    63 Scopus citations

    Abstract

    Background: Previous studies showed that adjunctive subantimicrobial dose doxycycline (SDD; 20 mg, twice daily) provides significant clinical benefits to scaling and root planing (SRP). A modified-release SDD formulation containing 40 mg doxycycline (SDD-40) to be taken once daily has been developed. The aim of this study was to investigate the efficacy of SDD-40 when used as an adjunct to SRP for the treatment of periodontitis. Methods: A 9-month, double-masked, randomized, placebo-controlled, multicenter study was conducted to test the efficacy of adjunctive SDD-40 in 266 subjects with periodontitis. Subjects were treated by SRP and randomized to receive SDD-40 or placebo for 9 months with evaluations at 3, 6, and 9 months. Results: Adjunctive SDD-40 provided significantly greater clinical benefits than placebo at all time points. At month 9, at sites with baseline probing depths (PD) ≥6 mm, 72% to 76% of sites in the SDD-40 group demonstrated clinically significant PD reductions and clinical attachment level (CAL) gains ≥2 mm compared to 56% to 58% of sites in the placebo group (P<0.0001); 48% to 52% of sites in the SDD-40 group demonstrated PD reductions and CAL gains ≥3 mm compared to 32% of sites in the placebo group (P<0.0001). In moderate sites (baseline PD 4 to 6 mm), adjunctive SDD-40 provided significant clinical benefits compared to placebo for mean CAL (all time points: P<0.05), PD (3 months: P= 0.002; 6 and 9 months: P= 0.001), and bleeding on probing (BOP) (3 months: P<0.01; 6 months: P<0.02; 9 months: P<0.05). In deep sites (baseline PD ≥7 mm), SDD-40 provided significant benefits over control for mean CAL (3 months: P<0.05; 6 and 9 months: P<0.01), PD (all time points: P<0.001), and BOP (3 months: P<0.05; 6 months: not statistically significant; 9 months: P<0.05). Compliance with study medication was high (>92%) with no significant differences in adverse events between groups and no evidence of microbiologically significant changes or development of antibiotic resistance in the subgingival flora in either group. Conclusion: SDD-40 used as an adjunct to SRP resulted in significantly greater clinical benefits than SRP alone in the treatment of periodontitis.

    Original languageEnglish
    Pages (from-to)440-452
    Number of pages13
    JournalJournal of Periodontology
    Volume79
    Issue number3
    DOIs
    StatePublished - Mar 2008

    Keywords

    • Double-masked method
    • Doxycycline/therapeutic use
    • Multicenter
    • Periodontitis/drug therapy

    ASJC Scopus subject areas

    • Periodontics

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