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

Qazvin University Of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Aphthous Stomatitis

Treatments: Drug: Diphenhydramine and Aluminium MgS; Drug: Ibuprofen, Diphenhydramine and Aluminium MgS

Study type: Interventional

Funder types: Other

Identifiers

NCT01293968

qums353

Details and patient eligibility

About

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)

Full description

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).

Enrollment: 37 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups

5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg

Experimental group

Treatment:

Drug: Ibuprofen, Diphenhydramine and Aluminium MgS

100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg

Active Comparator group

Treatment:

Drug: Diphenhydramine and Aluminium MgS