To evaluate the utility, safety and feeling of patients with respect to the use of SIM-990 (a double-layer film containing Triamcinolone Acetonide for application to the oral cavity), clinical trials were carried out at Second Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University and Department of Oral and Maxillofacial Surgery, Yokohama City University School of Medicine. The following results were obtained.
1) Of the 58 cases, 23 were males and 35 were females. The 20- to 29-year old group (26 cases) and 30- to 39-year old group (12 cases) were the most numerous. (21 aphthous stomatitis and 37 chronic rerurrent aphtha.)
2) One to two pieces of SIM-990 were applied to the affected part.
Application periods were 4 to 6 days in 49 cases and 7 to 9 days in 9 cases.
3) With respect to clinical improvement, improvement of contact pain was observed in 94.8 % (55/58), improvement of pain at meals of 94.8 % (55/58), reduced size of the lesion was 89.7 % (52/58) and alleviation of flare 94.8 % (55/58) .
4) With respect to the feeling of pain, 100.0 % (58/58) of the patients felt “no pain or a little pain” during application.
94.8 % (55/58) had “no specific feeling” or “slight feeling of a foreign matter”for feeling of adhesion.
Average duration of adhesion was more than 3 hours in 75.9 % (44/58) .
Adhesion to lesion for a long time had a superior parmaceutical property of this product.
5) Side effects were not reported in any of these cases.
6) Global improvement, global safety and utility were determined by clinical observation, feeling of patients and side effects.
For global improvement, “marked improvement” and “improvement”were 93.1 % (54/58) .
7) For global sefety, all cases were proved to be “safe.”
8) For utility rating, the cases considered to be “very useful” and “useful” were 93.1 % (54/58) .
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