Two multi-center studies evaluating locally delivered doxycycline hyclate,placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis

Background: The clinical efficacy and safety of doxycycline hyclate (8.5% w /w) delivered subgingivally in a biodegradable polymer (DH) was compared to placebo control (VC), oral hygiene (OH), and scaling and root planing (SRP ) in 2 multi-center studies; Methods: Each study entered 411 patients who demonstrated moderate to sever e periodontitis, Patients had 2 or more quadrants each with a minimum of 4 qualifying pockets greater than or equal to 5 mm that bled on probing. At l east 2 of the pockets were greater than or equal to 7 mm, Treatment with DH , VC, OH, or SRP was provided at baseline and again at month 4, Clinical pa rameters were recorded monthly. Results: DH and SRP resulted in nearly identical clinical changes over time in both studies. Mean 9 month clinical attachment level gain (ALG) was 0.8 mm for the DH group and 0.7 mm for the SRP group in Study 1, and 0.8 mm (D H) and 0.9 mm (SRP) in Study 2, Mean probing depth (PD) reduction was 1.1 m m for the DH group and 0.9 mm for the SRP group in Study 1 and 1.3 mm for b oth groups in Study 2, Frequency distributions showed an ALG greater than o r equal to 2 mm in 29% of DH sites versus 27% of SRP sites in Study 1 and 3 1% of DH sites versus 34% of SRP sites in Study 21 PD reductions greater th an or equal to 2 mm were seen in 32% of DH sites versus 31% of SRP sites in Study 1 and 41% of DH sites versus 43% of SRP sites in Study 2. Comparison s between DH, VC, and OH treatment groups showed DH treatment to be statist ically superior to VC and OH, Safety data demonstrated a benign safety prof ile with use of the DH product, Conclusions: Results of this trial demonstrate that treatment of periodonti tis with subgingivally delivered doxycycline in a biodegradable polymer is equally effective as scaling and root planing and superior in effect to pla cebo control and oral hygiene in reducing the clinical signs of adult perio dontitis over a 9-month period. This represents positive changes resulting from the use of subgingivally applied doxycycline as scaling and root Plani ng was not limited regarding time of the procedure or use of local anesthes ia.