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

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Brief Title

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

Official Title

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

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)
    

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 Phase

Phase 2

Study Type

Interventional


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

Condition

Aphthous Stomatitis

Intervention

Ibuprofen, Diphenhydramine and Aluminium MgS

Study Arms / Comparison Groups

 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

November 2010

Completion Date

February 2011

Primary Completion Date

January 2011

Eligibility 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
      

Gender

All

Ages

10 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Katayun Borhanmojabi, D.D.S,M.S, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations


NCT ID

NCT01293968

Organization ID

qums353


Responsible Party

Principal Investigator

Study Sponsor

Qazvin University Of Medical Sciences


Study Sponsor

Katayun Borhanmojabi, D.D.S,M.S, Study Chair, QUMS


Verification Date

May 2012