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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

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)

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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).

Conditions

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Aphthous Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg

Group Type EXPERIMENTAL

Ibuprofen, Diphenhydramine and Aluminium MgS

Intervention Type DRUG

3 times daily for 3 days

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

Group Type ACTIVE_COMPARATOR

Diphenhydramine and Aluminium MgS

Intervention Type DRUG

3 times daily for 3 days

Interventions

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Ibuprofen, Diphenhydramine and Aluminium MgS

3 times daily for 3 days

Intervention Type DRUG

Diphenhydramine and Aluminium MgS

3 times daily for 3 days

Intervention Type DRUG

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No