Aphthous Stomatitis Clinical Trial
Official title:
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable
prevalence . The most common aphthous ulcer treatments include applying topical agents such
as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.
The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an
analgesic mouthwash for a long time in order to decrease a great number of oral ulcers
symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory
potential prescribed in dental pains.
This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen,
Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be
participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS
while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.
All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes
before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days
and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a
scaled ruler which the zero point displays the zone of lack of pain and the 10th point was
considered as the zone of maximum pain).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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