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

Information source: Qazvin University Of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aphthous Stomatitis

Intervention: Ibuprofen, Diphenhydramine and Aluminium MgS (Drug); Diphenhydramine and Aluminium MgS (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Qazvin University Of Medical Sciences

Official(s) and/or principal investigator(s):
Katayun Borhanmojabi, D.D.S,M.S, Study Chair, Affiliation: QUMS
Katayun Borhanmojabi, D.D.S,M.S, Study Director, Affiliation: QUMS
Marjan Nasiri asl, PhD, Study Director, Affiliation: QUMS
Faeze Mirmiran, D.D.S, Principal Investigator, Affiliation: QUMS
Pantea Nazeman, student, Principal Investigator, Affiliation: QUMS

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)

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation

Secondary outcome: The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation

Detailed 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).

Eligibility

Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Dental faculty of Qazvin University of Medical Sciences, Qazvin, Iran, Islamic Republic of

Qazvin University of Medical sciences, Qazvin, Iran, Islamic Republic of

Additional Information

Starting date: November 2010
Last updated: May 16, 2012

Page last updated: August 23, 2015

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