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

Primary Purpose

Aphthous Stomatitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ibuprofen, Diphenhydramine and Aluminium MgS
Diphenhydramine and Aluminium MgS
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aphthous Stomatitis focused on measuring Aphthous Stomatitis, Ibuprofen, treatment efficacy

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dental faculty of Qazvin University of Medical Sciences
  • Qazvin University of Medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg

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

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 10, 2011
Last Updated
May 16, 2012
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01293968
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis
Keywords
Aphthous Stomatitis, Ibuprofen, treatment efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg
Arm Type
Experimental
Arm Title
100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen, Diphenhydramine and Aluminium MgS
Intervention Description
3 times daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine and Aluminium MgS
Intervention Description
3 times daily for 3 days
Primary Outcome Measure Information:
Title
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
Description
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
Time Frame
four days after the start of the study
Secondary Outcome Measure Information:
Title
The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
Description
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
Time Frame
4 days after the solution consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katayun Borhanmojabi, D.D.S,M.S
Organizational Affiliation
QUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katayun Borhanmojabi, D.D.S,M.S
Organizational Affiliation
QUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marjan Nasiri asl, PhD
Organizational Affiliation
QUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Faeze Mirmiran, D.D.S
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pantea Nazeman, student
Organizational Affiliation
QUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental faculty of Qazvin University of Medical Sciences
City
Qazvin
Country
Iran, Islamic Republic of
Facility Name
Qazvin University of Medical sciences
City
Qazvin
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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