Aphthous Stomatitis
Conditions
Keywords
Aphthous Stomatitis, Ibuprofen, treatment efficacy
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).
Interventions
DRUGIbuprofen, Diphenhydramine and Aluminium MgS
3 times daily for 3 days
DRUGDiphenhydramine and Aluminium MgS
3 times daily for 3 days
Sponsors
Qazvin University Of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen, Diphenhydramine and Aluminium MgS | 17 |
| Diphenhydramine and Aluminium MgS | 14 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | non-cooperation | 3 | 3 |
Baseline characteristics
| Characteristic | Diphenhydramine and Aluminium MgS | Ibuprofen, Diphenhydramine and Aluminium MgS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 16 Participants | 29 Participants |
| Age Continuous | 32.0 years STANDARD_DEVIATION 10 | 32.4 years STANDARD_DEVIATION 10.04 | 32.2 years STANDARD_DEVIATION 10.02 |
| Region of Enrollment Iran, Islamic Republic of | 14 participants | 17 participants | 31 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 |
Outcome results
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
Time frame: four days after the start of the study
Population: The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ibuprofen, Diphenhydramine and Aluminium MgS | Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | 3.176 scores in Visual Analogue Scale |
| Diphenhydramine and Aluminium MgS | Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | 3.821 scores in Visual Analogue Scale |
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
Time frame: 4 days after the solution consumption