Clinical trial NCT01293968: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aphthous Stomatitis
Keywords: Aphthous Stomatitis
Ibuprofen
treatment efficacy
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 37
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
timeFrame: four days after the start of the study
Secondary outcomes:
measure: The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
timeFrame: 4 days after the solution consumption
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Dental faculty of Qazvin University of Medical Sciences
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical sciences
Study officials:
affiliation: QUMS
name: Katayun Borhanmojabi, D.D.S,M.S
role: STUDY_CHAIR
affiliation: QUMS
name: Katayun Borhanmojabi, D.D.S,M.S
role: STUDY_DIRECTOR
affiliation: QUMS
name: Marjan Nasiri asl, PhD
role: STUDY_DIRECTOR
affiliation: QUMS
name: Faeze Mirmiran, D.D.S
role: PRINCIPAL_INVESTIGATOR
affiliation: QUMS
name: Pantea Nazeman, student
role: PRINCIPAL_INVESTIGATOR
References: