Clinical Trial: Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

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

Official Title: Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

Brief Summary: 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)

Detailed Summary:

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).


Sponsor: Qazvin University Of Medical Sciences

Current Primary Outcome: Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation [ Time Frame: four days after the start of the study ]

pain sensation was measured 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)) 4 days after the consumption of the solution


Original Primary Outcome: Efficacy of Ibuprofen, Diphenhydramine and Aluminium MgS measured by decrease in pain level,pain duration and burning sensation [ Time Frame: four days after the start of the study ]

pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solution


Current Secondary Outcome: The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation [ Time Frame: 4 days after the solution consumption ]

pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed


Original Secondary Outcome: Comparing the therapeutic efficacy of Ibuprofen, Diphenhydramine and Aluminium MgS with Diphenhydramine and Aluminium MgS in decreasing the pain level, pain duration and burning sensation [ Time Frame: 4 days after the start of study ]

pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both of the drugs was analyzed


Information By: Qazvin University Of Medical Sciences

Dates:
Date Received: February 10, 2011
Date Started: November 2010
Date Completion:
Last Updated: May 16, 2012
Last Verified: May 2012