Minor recurrent aphthous stomatitis. Recurrent oral aphthae
Conditions
Interventions
Intervention 1: Intervention group: Use of Ibuprofen Mucoadhesive Gel
Chemical composition: Ethanol 70%(10%w/w), Propyl-paraben (0.02%), Methyl-paraben (0.2%), D-mannitol (7.5%), HPMC k100 (8%), Carbopol 974p (2%), Glycerol (15%), Tween 80 (0.2%), Ibuprofen (5%), Water
each dose contains 25 mg of ibuprofen (equivalent to 75 mg 3 times a day), Duration of use: Until the lesion heals (maximum 7 days). Intervention 2: Control group: Placebo
the chemical composition and administration method will be similar to the original drug but without ibuprofen.
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men and women aged 18 to 50 years who have the ability to follow the doctor's recommendations who are willing to participate in the study and do not use painkillers during it who have a Aphthous ulcer (no more than 48 hours have passed since the lesion formed;) with a size smaller than 10 mm patients who have Aphthous ulcer in the lips and buccal mucosa (due to greater availability and fewer movements, which allow the mucusal adhesive to remain on the lesion)
Exclusion criteria
Exclusion criteria: Due to the possibility of drug interactions, people taking lithium, warfarin, oral hypoglycemic drugs, high-dose methotrexate, antihypertensive drugs, angiotensin-converting enzyme inhibitors, beta-blockers, and diuretics were excluded from the study Pregnancy or breastfeeding Ulcers as a manifestation of a systemic disease such as Behçet's disease, ulcerative colitis, Crohn's disease, or acquired immunodeficiency Use of narcotics, immunomodulating agents, and systemic antibiotics within 2 weeks prior to study entry Treatment with any topical or oral medication within 1 month prior to study entry Invasive dental procedure within 2 weeks prior to study entry A patient who uses toothpaste containing anti-inflammatory drugs People with conditions such as active gastrointestinal or cerebrovascular bleeding, uncontrolled heart failure, lupus, kidney failure, and liver failure or disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The distance between the 2 outer edges of the ulcer border in mm; lesions less than 1 mm in diameter will be considered healed. Timepoint: The day of referral (starting the use of the drug), the third, fifth and seventh day after that. Method of measurement: To determine the wound size, the researcher measures the distance between the 2 outer edges of the wound border in millimeters using a calibrated dental probe (D&G, Pakistan).;Patients are taught to determine the intensity of their pain based on a visual analogue scale. Patients will record their pain in a checklist 3 times a day after each meal and lesions with a pain value of 1 cm or less will be considered healed. Timepoint: 3 times a day until the lesion heals. Method of measurement: Using a visual analogue scale, so that the patient marks his pain level from 0 to 10 3 times a day after each meal on a 10 cm line. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbbas Abbasi
Mazandaran University of Medical Sciences
Outcome results
None listed