Therapeutic Effects of Ibuprofen, Diphenhydramine and Aluminium MgS on Recurrent Aphthous Stomatitis

Study Overview
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Brief Summary
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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 Description
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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).

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

Conditions
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Aphthous Stomatitis

Intervention / Treatment
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* Drug: Ibuprofen, Diphenhydramine and Aluminium MgS
* Drug: Diphenhydramine and Aluminium MgS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: possessing at least one painful aphthous ulcer in the last 3 days older than 10 years of age Exclusion Criteria: systemic disease or specific syndrome (such as Behcet's) pregnancy breastfeeding allergy to NSAIDs history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders consumption of anti-inflammatory medications in the last 24 hours

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg<br> | Drug: Ibuprofen, Diphenhydramine and Aluminium MgS<br>* 3 times daily for 3 days<br>|
| Active Comparator: 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg<br> | Drug: Diphenhydramine and Aluminium MgS<br>* 3 times daily for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | 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 | four days after the start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation | 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 | 4 days after the solution consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphthous Stomatitis, Ibuprofen, treatment efficacy