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 -