Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Aphthous Stomatitis |
Drug: Ibuprofen, Diphenhydramine and Aluminium MgS Drug: Diphenhydramine and Aluminium MgS |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis |
- Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation [ Time Frame: four days after the start of the study ] [ Designated as safety issue: No ]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 Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation [ Time Frame: 4 days after the solution consumption ] [ Designated as safety issue: No ]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
| Enrollment: | 37 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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).
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| 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| Iran, Islamic Republic of | |
| Dental faculty of Qazvin University of Medical Sciences | |
| Qazvin, Iran, Islamic Republic of | |
| Qazvin University of Medical sciences | |
| Qazvin, Iran, Islamic Republic of | |
| 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 |
More Information
No publications provided
| Responsible Party: | Pantea Nazeman, Miss, Qazvin University Of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01293968 History of Changes |
| Other Study ID Numbers: | qums353 |
| Study First Received: | February 10, 2011 |
| Results First Received: | May 5, 2011 |
| Last Updated: | May 16, 2012 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Qazvin University Of Medical Sciences:
|
Aphthous Stomatitis Ibuprofen treatment efficacy |
Additional relevant MeSH terms:
|
Stomatitis Stomatitis, Aphthous Mouth Diseases Stomatognathic Diseases Diphenhydramine Promethazine Ibuprofen Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics Dermatologic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on June 17, 2013