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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg | Experimental |
| |
| 100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen, Diphenhydramine and Aluminium MgS | Drug | 3 times daily for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | four days after the start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 days after the solution consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katayun Borhanmojabi, D.D.S,M.S | QUMS | Study Chair |
| Katayun Borhanmojabi, D.D.S,M.S | QUMS | Study Director |
| Marjan Nasiri asl, PhD | QUMS | Study Director |
| Faeze Mirmiran, D.D.S | QUMS | Principal Investigator |
| Pantea Nazeman, student | QUMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental faculty of Qazvin University of Medical Sciences | Qazvin | Qazvin Province | Iran | |||
| Qazvin University of Medical sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen, Diphenhydramine and Aluminium MgS | |
| FG001 | Diphenhydramine and Aluminium MgS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen, Diphenhydramine and Aluminium MgS | |
| BG001 | Diphenhydramine and Aluminium MgS | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS | Posted | Mean | 95% Confidence Interval | scores in Visual Analogue Scale | four days after the start of the study |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen, Diphenhydramine and Aluminium MgS |
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Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Katayun Borhanmojabi | Qazvin University of Medical Sciences | 09127841440 | ka.mojabi@yahoo.com |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Diphenhydramine and Aluminium MgS | Drug | 3 times daily for 3 days |
|
| Qazvin |
| Qazvin Province |
| Iran |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Diphenhydramine and Aluminium MgS | 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 |
|
|
| Secondary | 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 | Not Posted | scales in Visual Analogue Scale | 4 days after the solution consumption |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Diphenhydramine and Aluminium MgS | 0 | 14 | 0 | 14 |
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |