PT-01 is a controlled-release insert into the periodontal pocket. It consists of fast- and sustained-release parts containing ofloxacin. The ofloxacin level effective for periodontopathic microorganisms was maintained in the pocket for about 7 days afer insertion of PT-01. This study was designed to compare the clinical effectiveness and safety of inserting with and without PT-01. Eighty-three patients suffering from acute periodontal infections received crevicular irrigation and were assigned into PT-01 (T) and control (C) groups. PT-01 was inserted into some periodontal pockets of the affected teeth in T group at day 0. The average dose was 1.05±0.74 mg as ofloxacin. Clinical symptoms (spontaneous pain, tenderness, oppressive pain at chewing, gingival swelling, gingival flare, tooth mobility, bleeding on probing, pus discharge, and probing depth) were evaluated at day 0, 1, 3 and 7.
The following results were obtained:
1) All symptoms except for the tooth mobility were more significantly improved in T group than in C.
2) The clinical efficacy rate was 84.4% for the T group (45 cases) and 9.4% for the C group (32 cases) . The efficacy rate of T group was significantly (p<0.001) superior to that of C.
3) No side effects were observed in all 83 cases including 47 cases inserted PT-01.
From the above results, the topical chemotherapy using PT-01 could be effective for the treatment of acute periodontal infections.