Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease.
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) > or =6 mm, 72% to 76% of sites in the SDD-40 group demonstrated clinically significant PD reductions and clinical attachment level (CAL) gains > or =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 > or =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 > or =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.


CONCLUSIONS
SDD-40 used as an adjunct to SRP resulted in significantly greater clinical benefits than SRP alone in the treatment of periodontitis.
Preshaw
Philip M
PM
Department of Periodontology, School of Dental Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, U.K. p.m.preshaw@ncl.ac.uk
Novak
M John
MJ
Mellonig
James
J
Magnusson
Ingvar
I
Polson
Alan
A
Giannobile
William V
WV
Rowland
Randal W
RW
Thomas
John
J
Walker
Clay
C
Dawson
Dolphus R
DR
Sharkey
Dennis
D
Bradshaw
Mark H
MH
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001421:Bacteria, Anaerobic / Q000302:isolation & purification; D015169:Colony Count, Microbial; D003131:Combined Modality Therapy; D003773:Dental Plaque / Q000382:microbiology; D012534:Dental Scaling; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D010518:Periodontitis / Q000188:drug therapy* / Q000628:therapy*; D018709:Statistics, Nonparametric
D000900:Anti-Bacterial Agents; D004318:Doxycycline