Study aim:
Determining the effectiveness of ibuprofen-containing mucoadhesive on minor recurrent aphthous stomatitis
Design:
Controlled clinical trial, with parallel groups, double-blind, randomized, phase 3 on 44 patients, Randomization with random allocation software 2
Settings and conduct:
Touba Dental Clinic, Mazandaran University of Medical Sciences
Intervention method in the intervention group (ibuprofen) and control (placebo): Use of mucusal adhesive 3 times a day for 30 minutes (without eating or drinking during use)
(In addition to the examination on the day of visit), the patient must return on the third, fifth and seventh days to check the pain level with a visual analog scale, the size of the wound with a probe
In this double-blind study (researcher, analyst and participant) for blinding, codes A (ibuprofen) and B (placebo) will be generated using software. Finally, the codes will be placed in a sealed envelope and the sample number will be written on the envelope. These envelopes, along with the adhesive mucus, will be in dark packaging with the same color and shape.
Participants/Inclusion and exclusion criteria:
Inclusion: Men and women 18 to 50 years of age; having aphthous ulcers (within 48 hours of lesion formation, with a size smaller than 10 mm); aphthous lesions on the lips and buccal mucosa
Exclusion: Pregnancy or lactation; ulcers as a manifestation of a systemic disease; taking nonsteroidal anti-inflammatory drugs, narcotics, immunomodulators, analgesics; people with diseases such as active gastrointestinal or cerebrovascular bleeding, uncontrolled heart failure, lupus, renal failure and liver failure or disease
Intervention groups:
In the intervention and placebo groups, the medication will be applied 3 times daily (the patient should refrain from eating and drinking for 30 minutes during use).
Main outcome variables:
Pain level; Ulcer size
IRCTID: IRCT20241208063987N1