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

TY - JOUR

T1 - Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease

AU - Preshaw, Philip M.

AU - Novak, M. John

AU - Mellonig, James

AU - Magnusson, Ingvar

AU - Polson, Alan

AU - Giannobile, William V.

AU - Rowland, Randal W.

AU - Thomas, John

AU - Walker, Clay

AU - Dawson, Dolphus R.

AU - Sharkey, Dennis

AU - Bradshaw, Mark H.

PY - 2008/3/1

Y1 - 2008/3/1

N2 - 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.

AB - 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.

KW - Double-masked method

KW - Doxycycline/therapeutic use

KW - Multicenter

KW - Periodontitis/drug therapy

U2 - 10.1902/jop.2008.070375

DO - 10.1902/jop.2008.070375

M3 - Article

C2 - 18315426

AN - SCOPUS:41449105532

SN - 0022-3492

VL - 79

SP - 440

EP - 452

JO - Journal of Periodontology

JF - Journal of Periodontology

IS - 3

ER -