MULTICENTER COMPARATIVE-EVALUATION OF SUBGINGIVALLY DELIVERED SANGUINARINE AND DOXYCYCLINE IN THE TREATMENT OF PERIODONTITIS .2. CLINICAL-RESULTS

THE CLINICAL SAFETY AND EFFECTIVENESS of a subgingivally delivered bio degradable drug delivery system containing either 10% doxycycline hycl ate (DH), 5% sanguinarium chloride (SC) or no agent (VC) was evaluated in a 9-month multi-center trial. The study was a randomized parallel design with 180 patients who demonstrated moderate to severe periodont itis. All patients had at least two quadrants with a minimum of four q ualifying pockets greater than or equal to 5 mm that bled on probing. Two of the qualifying pockets were required to be greater than or equa l to 7 mm. At baseline and at 4 months all qualified sites were treate d with the test article administered via syringe. Probing depth reduct ion (PDR), attachment level gain (ALG), bleeding on probing reduction (BOP), and plaque index were determined monthly. Analysis of efficacy data from the 173 efficacy-evaluable patients indicated that all treat ments gave significant positive clinical changes from baseline at all subsequent timepoints. DH was superior to SC and VC in PDR at all time points (P less than or equal to 0.01 to 0.001) with a maximum reductio n of 2.0 mm at 5 months. For ALG, DH was superior to VC at months 2, 3 , 4, 5, 6, 8, and 9 (P less than or equal to 0.04 to 0.002) and superi or to SC at months 5, 6, 7, 8, and 9 (P less than or equal to 0.01 to 0.001) with a maximum ALG of 1.2 mm at 6 months. For BOP reduction, DH was superior to VC at all time points (P less than or equal to 0.05) and to SC at months 3, 5, 6, 8, and 9 (P less than or equal to 0.03). For DH, the maximum ALG in deep (greater than or equal to 7 mm) pocket s was 1.7 mm and PDR 2.9 mm compared to 0.8 mm and 1.6 mm, respectivel y for moderate (5 to 6 mm) pockets. Test articles were applied without anesthesia and no serious adverse events occurred in the trial. The r esults of this study indicate that 10% doxycycline hyclate delivered i n a biodegradable delivery system is an effective means of reducing th e clinical signs of adult periodontitis and exhibits a benign safety p rofile.