Clinical Trial: Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

Background:

Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids .

Methods:

A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets.

Purpose of the research:

To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS).

Study hypothesis:

Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.

Detailed Summary:

Scientific Background:

Recurrent painful canker sores within the mouth (Recurrent aphthous stomatitis, RAS) are a common phenomenon in Primary Medicine (1,2). The term "aphthai" in Greek means a condition within the mouth and is attributed to Hippocrates. (1) RAS is characterized by small, recurrent, painful canker sores in the mouth. These sores have characteristic round or elliptical ulcerations with sharp edges. The sores have a red halo surrounding them and a base with a yellowish or grey color (1,3). Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50% (2).

RAS is idiopathic in most cases. A possible cause is frequently a local injury or stress. Other possible causes include systemic illness, nutritional deficiency, sensitivity or allergy to certain foods, illness that effect the immune system and medication. Even though RAS can be associated with celiac disease or Behcet's disease, most of the cases patients are presented with this problem there is no other complaint or symptom and the patient is considered healthy.

Since the cause of the condition is unknown, Diagnosis is based on the patient's history and on a physical examination. There is no laboratory test that can substantiate or negate the condition (4-7).

In medical literature different approaches for treatment are described: treatment with various natural vitamins (8), local ointments (9), disinfectant agents for local treatment (10), local antibiotic ointments (11), non-steroidal anti-inflammatory ointments (NSAID)(12), local cortisone-steroids (13), and even medication on the basis of immune-depressants of the immune system and systematic steroids (14-16).