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Clinical studies
Bye Mouth Ulcer!™ is a clinically proven product and a class 1 medical device. Bye Mouth Ulcer! has been thoroughly researched on its effectiveness, tolerance and treatment for mouth ulcers.
A range of clinical studies have demonstrated the effect of and tolerance to, the active substances in Bye Mouth Ulcer!. A summary of the selection of the studies is given below.
Studies on Bye Mouth Ulcer!™
Therapeutic trials with Bye Mouth Ulcer! on patients with Aphthous ulcers
12 patients, 6 men and 6 women. Applying dimethicon 4x per day.
The number of mouth ulcers reduced during the treatment. After 7 days a total of only seven mouth ulcers remained. The pain caused by the mouth ulcers was substaintially reduced during treatment. In more than 50% of the cases, the pain was relieved immediatly after the dimethicon had been applied. Pain relief was apparent within 8 minutes. 95% of the patients indicated that the effect of dimethicon was "very good". Tolerance was also indicated to be "very good" by both the GP and the patients. There were no side-effects.
A multicenter, placebo-controlled randomized trial to evaluate the efficacy and tolerability of Bye Mouth Ulcer!. (dimethicone), tetracaine-comb and placebo in patients with mouth ulcers
Double-blind, placebo controlled, randomised investigation. 313 patients. Application 4x per day, for a maximum of 14 days.
The diameter of the mouth ulcers reduced. Mouth ulcers were healed within 8 days. Pain was relieved within 1 minute. Tolerance was indicated to be "very good" by more then 90% of the participants. The taste was considered to be "good" in 45% of the cases.
Placebo-controlled, randomised double-blind study with dimethicone and lidocaine comb. in patients with recurrent aphthous ulcers
The study was conducted over a period of 14 days on a total of 294 patients of both sexes ages 10 and up. All of them suffered from recurrent aphthous ulcers. Since the therapeutic objective was pain reduction, only patients were incorporated who had entered at least 3 cm on a visual analogue scale.
All of the medicinal products produced a pronounced reduction in pain. The diameter of the aphthous ulcers decreased in all patient groups over the 14-day observation phase without resulting in significant differences. In the scope of the investigations regarding the tolerability of the different medicinal preparations, evaluated by the patients, the evaluation of the VAS scores indicated that the DIHEC film-forming substance dispersion was perceived to be the most pleasant, followed by lidocaine.
It is conspicuous that the dimethicone complex of film-forming substances yielded similarly reliable effects in the acute treatment of recurrent aphthous ulcers as the local anaesthetic lidocaine. Since the dispersion lacks a local anaesthetic effect in the sense of the definition, a different mechanism of action must be at work here. Based on the considerations presented in the introduction, one can assume that the effect of the aphthous ulcer pain is produced from the covering affect at the base of the aphthous ulcer, not from the local anaesthetic effect.
This assessment is reflected in the physician’s assessment on tolerability. The dispersion ended up with the best results. Lidocaine was rated as being considerably worse.
Monocentric, randomised study with dimethicone and lidocaine in HIV patients with oral
mucosal lesions and oral ulcerations (1996)
A DIHEC dispersion was compared with lidocaine in a randomised, monocentric, singleblind (the patient could not recognise the active substance or comparative product) study in HIV patients suffering from oral mucosal lesions or oral ulcerations. It must be critically noted that it could not be discerned from the study documents which illnesses were subsumed under “oral mucosal lesions”. The target parameters were the effectiveness and tolerability of the DIHEC film-forming substance combination. 40 patients were incorporated, of which 20 received the film-forming substance combination (16 mg per day maximum) as a gel and 20 received lidocaine gel (40 mg per day). 6 patients in the Bye Mouth Ulcer!™ group (DIHEC dispersion) and 5 patients in the lidocaine group discontinued the study prematurely.
