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The efficacy of amlexanox OraDisc on the prevention of recurrent minor aphthous ulceration. 2006

B Murray, and P A Biagioni, and P-J Lamey
The Oral Science Research Centre, School of Dentistry, Queen's University Belfast, Royal Group Hospitals and Dental Hospital, Belfast, UK.

BACKGROUND The study was designed to determine the efficacy of OraDisc (active component 2 mg amlexanox) on the prevention of aphthous ulcers treated at the prodromal stage. METHODS Thermographic imaging was used to confirm the presence of a prodromal ulcer. Fifty-two patients were randomized to receive OraDisc (N = 26) or vehicle patches (N = 26). Patches were applied four times a day for 72 h over the prodromal area. The percentage of subjects who developed an ulcer at 72 h was compared between groups using the Fisher's exact test. RESULTS About 50% of subjects in the OraDisc group developed an ulcer by day 4 compared with 69% in the vehicle group. Erythema score, ulcer size, pain scores and thermographically active area and temperature all showed trends towards healing in the OraDisc group. CONCLUSIONS The OraDisc prevents ulcers from developing when compared with the vehicle patch.

UI MeSH Term Description Entries
D008297 Male Males
D009061 Mouth Mucosa Lining of the ORAL CAVITY, including mucosa on the GUMS; the PALATE; the LIP; the CHEEK; floor of the mouth; and other structures. The mucosa is generally a nonkeratinized stratified squamous EPITHELIUM covering muscle, bone, or glands but can show varying degree of keratinization at specific locations. Buccal Mucosa,Oral Mucosa,Mucosa, Mouth,Mucosa, Oral
D010146 Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. Suffering, Physical,Ache,Pain, Burning,Pain, Crushing,Pain, Migratory,Pain, Radiating,Pain, Splitting,Aches,Burning Pain,Burning Pains,Crushing Pain,Crushing Pains,Migratory Pain,Migratory Pains,Pains, Burning,Pains, Crushing,Pains, Migratory,Pains, Radiating,Pains, Splitting,Physical Suffering,Physical Sufferings,Radiating Pain,Radiating Pains,Splitting Pain,Splitting Pains,Sufferings, Physical
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D012008 Recurrence The return of a sign, symptom, or disease after a remission. Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D001831 Body Temperature The measure of the level of heat of a human or animal. Organ Temperature,Body Temperatures,Organ Temperatures,Temperature, Body,Temperature, Organ,Temperatures, Body,Temperatures, Organ
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004890 Erythema Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of disease processes. Erythemas
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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