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

• Sponsor: Qazvin University Of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01293968
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 18.5
• Patients Per Site Per Month: 6.1

Study Details

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)

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 Design

• Study Type: Interventional
• 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: Nov 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dental faculty of Qazvin University of Medical Sciences	Qazvin		Iran, Islamic Republic of
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pantea Nazeman, Miss, Qazvin University Of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01293968
• Other Study ID Numbers: qums353
• First Posted: Feb 11, 2011
• Last Update Posted: Jun 20, 2012
• Last Verified: May 1, 2012

• Keywords provided by Pantea Nazeman, Miss, Qazvin University Of Medical Sciences: Aphthous Stomatitis; Ibuprofen; treatment efficacy
• Additional relevant MeSH terms: Stomatitis; Stomatitis, Aphthous; Diphenhydramine; Promethazine; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Ibuprofen, Diphenhydramine and Aluminium MgS	Diphenhydramine and Aluminium MgS
Arm/Group Description
Period Title: Overall Study
STARTED	20	17
COMPLETED	17	14
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Ibuprofen, Diphenhydramine and Aluminium MgS	Diphenhydramine and Aluminium MgS	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	17	14	31
Age (Count of Participants)
<=18 years	1 5.9%	1 7.1%	2 6.5%
Between 18 and 65 years	16 94.1%	13 92.9%	29 93.5%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.4 (10.04)	32.0 (10.0)	32.2 (10.02)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	7 50%	18 58.1%
Male	6 35.3%	7 50%	13 41.9%
Region of Enrollment (participants) [Number]
Iran, Islamic Republic of	17 100%	14 100%	31 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS

Arm/Group Title	Ibuprofen, Diphenhydramine and Aluminium MgS	Diphenhydramine and Aluminium MgS
Arm/Group Description	the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days	the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
Measure Participants	17	14
Mean (95% Confidence Interval) [scores in Visual Analogue Scale]	3.176	3.821

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Ibuprofen, Diphenhydramine and Aluminium MgS		Diphenhydramine and Aluminium MgS
Arm/Group Description
All Cause Mortality
	Ibuprofen, Diphenhydramine and Aluminium MgS		Diphenhydramine and Aluminium MgS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ibuprofen, Diphenhydramine and Aluminium MgS		Diphenhydramine and Aluminium MgS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Ibuprofen, Diphenhydramine and Aluminium MgS		Diphenhydramine and Aluminium MgS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/14 (0%)

Limitations/Caveats

Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.