EFFECTIVENESS OF A MEDICAMENT CONTAINING SILICON DIOXIDE, ALOE, AND ALLANTOIN ON APHTHOUS STOMATITIS

This research protocol was designed to test the effectiveness of a gel containing silicon dioxide, aloe vera, and allantoin in the healing o f recurrent aphthous ulcers. The subjects were patients with histories of developing multiple ulcers on the oral mucosa during a 3-to-4-mont h period. The parameters used to evaluate healing were number of lesio ns during a 3-to-4-month period, length of the interval between ulcers , size of ulcers, and pain from ulcers. An approach was used in which data were accumulated from diaries maintained by the subjects througho ut the study intervals. Because 3 active substances were present in th e gel, a preliminary study (study I) was performed to indicate the eff ect of each active substance and each combination. In this phase, diff erent combinations of the substances were compared with the use of the 23 factorial experimental design. The results of this study demonstra ted that statistical differences in the durations of lesions (P = .017 ) were present when all 3 substances were included in the gel. In the next study (study II), which was initiated to test the results of stud y I, additional subjects were divided into 2 groups; one used a contro l gel with silicon dioxide, and the other a gel with all 3 active subs tances. Study II found no statistical differences in the parameters wh en the 2 groups were compared. In study Ill, a modified crossover desi gn was used with the subjects of study II, and a significant differenc e was found in lesion-free intervals (P = .0335) and length of time fo r the study (P = .0001). The differences in lesion intervals may have been caused by the differences in study length. Alteration in the occu rrence of aphthous ulcers was demonstrated by the reduction in numbers of lesions in study I and by the increase in length of intervals betw een lesions in study III. However, a consistent pattern was not presen t; this indicated a lack of effect of the gel on aphthous ulcers.