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Effect of Propolis gel versus placebo on wound treatment in patients with recurrent minor aphtous ulceratio

Phase 2
Conditions
aphtous ulcers.
Recurrent oral aphthae
Registration Number
IRCT201411269014N49
Lead Sponsor
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

(a) age of 15 to 60 years; (b) having recurrent minor aphtous ulcers; (c) history of disease for more than one year with at least two recurrence a year; (d) having 1 to 6 ulceration if each episode; (e) less than 72 hours from the begging of the ulceration; (f) the duration of healing without medication is not more than 7 days; (g) the size of ulcers is not more than 1 cm.
Exclusion criteria: (a) hypersensitivity to drug or plant; (b) treatment with immunosuppressive drugs during the last month; (c) using systemic antibiotic during the last two weeks; (d) using anti-inflammatory drugs or anti-histamine during the last month; (e) using any drug for treatment of aphtous ulcers during the last 72 hours; (f) having systemic diseases such as endocrine, immunologic, hematologic, metabolic, rheumatoid arteritis, and hormonal disorders; (g) during pregnancy or breastfeeding; complete or partial denture or unsuitable restoration of a tooth or appliance ortodency in close contact with aphtous ulcers; (h) cigarette smoking or drinking alcohol; (i) affected with major aphtous ulcers or herpetiform ulcers.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Measuring the diameter of lesions. Timepoint: before and 3 and 6 days after treatment. Method of measurement: by physical examination.;Measuring the pain severity. Timepoint: before and 3 and 6 days after treatment. Method of measurement: by taking history.
Secondary Outcome Measures
NameTimeMethod
Presence of erythema or exudates. Timepoint: 3 and 6 days after treatment. Method of measurement: by physical examination.
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