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

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ClinicalTrials.gov Identifier: NCT01293968
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Pantea Nazeman, Qazvin University Of Medical Sciences

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)

Condition or disease Intervention/treatment Phase
Aphthous Stomatitis Drug: Ibuprofen, Diphenhydramine and Aluminium MgS Drug: Diphenhydramine and Aluminium MgS Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Study Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011


Arm Intervention/treatment
Experimental: 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg Drug: Ibuprofen, Diphenhydramine and Aluminium MgS
3 times daily for 3 days
Active Comparator: 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg Drug: Diphenhydramine and Aluminium MgS
3 times daily for 3 days



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293968


Locations
Iran, Islamic Republic of
Dental faculty of Qazvin University of Medical Sciences
Qazvin, Iran, Islamic Republic of
Qazvin University of Medical sciences
Qazvin, Iran, Islamic Republic of
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Investigators
Study Chair: Katayun Borhanmojabi, D.D.S,M.S QUMS
Study Director: Katayun Borhanmojabi, D.D.S,M.S QUMS
Study Director: Marjan Nasiri asl, PhD QUMS
Principal Investigator: Faeze Mirmiran, D.D.S QUMS
Principal Investigator: Pantea Nazeman, student QUMS

Responsible Party: Pantea Nazeman, Miss, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01293968     History of Changes
Other Study ID Numbers: qums353
First Posted: February 11, 2011    Key Record Dates
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012
Last Verified: May 2012

Keywords provided by Pantea Nazeman, Qazvin University Of Medical Sciences:
Aphthous Stomatitis
Ibuprofen
treatment efficacy

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases
Ibuprofen
Diphenhydramine
Promethazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents