TY - JOUR
T1 - The efficacy and safety of 50 mg penicillin G potassium troches for recurrent aphthous ulcers
AU - Kerr, A. Ross
AU - Drexel, Catherine A.
AU - Spielman, Andrew I.
PY - 2003/12
Y1 - 2003/12
N2 - Purpose. To determine both the efficacy and safety of the topical application of 50 mg penicillin G potassium troches (Cankercillin™) in the treatment of minor recurrent aphthous stomatitis (RAS). Study design. The investigation used a phase 2 double-blind, randomized placebo-controlled trial with a no-treatment arm. Subjects with minor aphthous ulcers of duration <48 hours were followed for 1 week. The primary endpoint for efficacy was time (days) to complete ulcer resolution, and the secondary endpoint was time (days) to complete pain relief. Results. Thirty-one, 33, and 36 subjects were randomized to the active treatment, placebo, and no-treatment arms, respectively. Baseline findings were heterogeneous across arms. Subjects who received penicillin G treatment had complete ulcer healing and pain relief significantly earlier than those in the placebo and no-treatment arms. No allergic reactions were observed. Conclusions. Topical penicillin G, by mechanisms which remain unclear, reduces the time of healing and pain relief of minor aphthous ulcers with minimal safety concerns. Larger phase 3 studies are necessary to confirm these findings.
AB - Purpose. To determine both the efficacy and safety of the topical application of 50 mg penicillin G potassium troches (Cankercillin™) in the treatment of minor recurrent aphthous stomatitis (RAS). Study design. The investigation used a phase 2 double-blind, randomized placebo-controlled trial with a no-treatment arm. Subjects with minor aphthous ulcers of duration <48 hours were followed for 1 week. The primary endpoint for efficacy was time (days) to complete ulcer resolution, and the secondary endpoint was time (days) to complete pain relief. Results. Thirty-one, 33, and 36 subjects were randomized to the active treatment, placebo, and no-treatment arms, respectively. Baseline findings were heterogeneous across arms. Subjects who received penicillin G treatment had complete ulcer healing and pain relief significantly earlier than those in the placebo and no-treatment arms. No allergic reactions were observed. Conclusions. Topical penicillin G, by mechanisms which remain unclear, reduces the time of healing and pain relief of minor aphthous ulcers with minimal safety concerns. Larger phase 3 studies are necessary to confirm these findings.
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U2 - 10.1016/j.tripleo.2003.08.024
DO - 10.1016/j.tripleo.2003.08.024
M3 - Article
C2 - 14676759
AN - SCOPUS:0345734101
SN - 1079-2104
VL - 96
SP - 685
EP - 694
JO - Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics
JF - Oral surgery, oral medicine, oral pathology, oral radiology, and endodontics
IS - 6
ER -