Preventive effects of bioactive B12 in adhering discs for RAU

Recurrent aphthous ulceration (RAU) causes significant pain and oral dysfunction. Studies suggest that in cases of B12 deficiency and RAU, replacement therapy can be effective in reducing ulceration. Studies using B12 in swallowed tablets for RAU without B12 deficiency are equivocal. A case study suggests that high doses of injected cyanocobalamin can cause remission of ulcers with borderline B12 deficiency.

Objectives: In subjects who experience at least one ulcer each month but have no known B12 deficiency, we assessed the preventive effect of daily delivery into saliva of a bioactive form of cobalamin, methylcobalamin, delivered via a slowly dissolving disc that adheres to teeth or keratinized gingiva (Avamin™ Melts®).

Methods: Fifty-five subjects were randomly divided into two groups and given 30 discs with instructions to use two initially and then one each succeeding day, placing it near an ulcer when present. Active subjects received discs with 500 mcg methylcobalamin. Placebo subjects received discs with food coloring. Each group was subdivided into a group using large diameter discs with protein gum adhesive and a group using small diameter discs with vegetable gum adhesive.

Results: Data was collected over one month from 26 active and 20 placebo subjects. In the active group, 20 of 26 (77%) reported improvement while only 9 of 20 (45%) in the placebo reported benefit (Chi 4.55, p<.03). Perceived pain reduction was also significantly different between groups (Chi 4.82, p <.02). Although more active than placebo subjects reported reduced frequency and duration of ulcers, the differences were not significant in this number of subjects. Disc size and adhesive type did not show significant effects.

Conclusions: Daily use of high dose bioactive B12 (methylcobalamin) delivered into saliva via an adhering dissolvable disc is effective in reducing pain of aphthous ulceration and results in significant perception of improvement.