THE USE OF LOCALLY-DELIVERED DOXYCYCLINE IN THE TREATMENT OF PERIODONTITIS - CLINICAL-RESULTS

The clinical safety and effectiveness of a subgingivally-delivered bio degradable drug delivery system containing doxycycline hyclate (DH) ha s been evaluated in 3 large 9-month multicenter randomized parallel-de sign controlled clinical trials. A total of 1002 patients having at le ast 3 quadrants with a minimum of 4 qualifying pockets greater than or equal to 5 mm that bled on probing were enrolled. Each subject had gr eater than or equal to 7 mm probing depths in 2 of the qualifying pock ets. Study 1 (n = 180) compared DH to sanguinarine chloride (SC) and v ehicle control (VC). Study 3 (n = 411) and study 3 (n = 411) compared DH to VC, scaling and root planing (SRP), and oral hygiene (OH). Clini cal measurements included probing depth reduction (PDR), attachment le vel gain (ALG), bleeding on probing reduction (BOP) and plaque index ( PI). Analysis of efficacy data from these 3 trials show all treatments gave significant positive clinical changes from baseline at most time points. Study 1 results indicate that DH was superior to SC and VC in PDR at all time points. Similar results were obtained for ALG when DH was compared to SC and VC. For BOP reductions, DH was superior to VC at all time points and to SC at months 5 through 9. For DH, mean ALG i n deep (greater than or equal to 7 mm) pockets was 1.4 mm; mean PDR fo r DH was 2.6 mm. For moderate (5 to 6 mm) pockets, ALG was 0.8 mm and PDR 1.5 mm. Studies 2 and 3 reported mean month 9 ALG for SRP as 0.7 m m and 0.8 mm, respectively. For DH, ALG was 0.8 mm in both studies 2 a nd 3. At month 9 in studies 2 and 3, 29% and 31% of DH sites and 27% a nd 34% of SRP sites showed ALG greater than or equal to 2 mm. Probing depth reductions followed the same pattern, with 32% of DH sites and 3 2% of SRP sites showing greater than or equal to 2 mm PD reductions in study 1, and 41% of DH and 43% of SRP sites showing PDR of greater th an or equal to 2 mm in study 3. Comparisons between DH, VC, and OH tre atment groups in studies 2 and 3 showed DH treatment was statistically superior to VC and OH at most time points. Results of these 3 large c linical trials demonstrate that treatment of periodontitis with 10% do xycyline hyclate in a bioabsorbable delivery system is equally as effe ctive as SRP and superior in effect to VC and OH in reducing the clini cal signs of adult periodontitis.