None listed
Conditions
Brief summary
Recurrent aphthous ulcer is chronic inflammatory disease without definite etiology. The effectiveness of topical antibiotics has been validated in the treatment of recurrent aphthous ulcer, such as chlorhexidine, tetracycline, aureomycin, and chlortetracycline. Although they could dramatically reduce pain and healing time of ulceration, their side effects could not be neglected. For these shortcomings, it is urgent to explore some other effective and safe antibiotics to treat recurrent aphthous ulcer. Interestingly, penicillin G potassium, which is a narrow-spectrum antibiotic with known bacteriocidal effects against oral bacteria, has been proved effective and safe in treating recurrent aphthous ulcer when topically applied in America. But no comfirmative trial has be conducted in other ethnic groups. We conducted this randomized, double-blined, placebo and blank controlled, multicenter clinical trial, in order to clinically determine both the effectiveness and safety of penicillin G potassium troches when applied topically for the treatment of recurrent minor aphthous ulcer in a Chinese cohort.
Interventions
The 50mg of penicillin G potassium troches were topically applied by subjects themselves 4 times a day for 4 days.
Sponsors
West China Hospital, Sichuan University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
12 Years to 73 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females aged 12 years or older, who can follow doctor’ advice. 2. Willingness to participate and sign the informed consent forms. 3. History of minor recurrent ulcers, with expectation that their ulcers normally take 5 or more days to resolve without treatment. 4. Presenting with 1 to 3 aphthous ulcers (less than 48 hours’ duration) with a size no greater than 10 mm in diameter. 5. Negative reaction to penicillin skin test. 6. Normal sense of pain, without anesthesia or paresthesia. 7. Ulcers must be in locations easily accessible for evaluation and treatment.
Exclusion criteria
1. History of allergies to penicillin, cephalosporins or B (beta)- lactamantibiotics. 2. Pregnancy and lactation (Urine human chorionic gonadotrophin-positive) 3. Concurrent oral fungal/viral infections. 4. Other concurrent clinical conditions posing a risk to the patient or study, including active tuberculosis or other infectious diseases spread by respiratory droplets, unstable or uncontrolled medical conditions, and a present/recent history of cocaine/heroin drug or alcohol abuse. 5. Ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohn’s disease, Behcet’s syndrome, or serious anemia. 6. Treatment with systemic steroid, oral retionoids or other immunomodulatory agents within 1 month of study entry. 7. Use of non-steroidal anti-inflammatory drug, acetaminophen, or oral antihistamines within 1 month of study entry. 8. Treatment with any oral topical medication within 2 weeks of study entry. 9. Treatment of the ulcer with any preparation or medication within 48 hours of study entry. 10. Treatment with asystemic antibiotic within 2 weeks of study entry. 11. Dental surgery within 2 weeks of study entry. 12. Orthodontic braces or retainer that might come in to contact with the ulcer. 13. Use of chewing tobacco products, smoking pipes, or smoking cigars. Cigarette smokers will be accepted.
Outcome results
None listed