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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pantea Nazeman, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01293968
First received: February 10, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Aphthous Stomatitis
Drug: Ibuprofen, Diphenhydramine and Aluminium MgS
Drug: Diphenhydramine and Aluminium MgS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 37
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Pantea Nazeman, Miss, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01293968     History of Changes
Other Study ID Numbers: qums353
Study First Received: February 10, 2011
Results First Received: May 5, 2011
Last Updated: May 16, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on September 16, 2014