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A clinical evaluation of penicillin G potassium in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and blank controlled, multicenter tr

A clinical evaluation of penicillin G potassium in the treatment of minor recurrent aphthous ulceration in a Chinese cohort: a randomized, double-blinded, placebo and blank controlled, multicenter tr

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000421
Enrollment
Unknown
Registered
2009-05-28
Start date
2001-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minor recurrent aphthous ulcer

Interventions

Placebo-controlled group:patients were instructed to apply 1 placebo troche topically to the appointed ulcer 4 times a day (after meals and before bedtime).
blank-controlled group:no intervention
Penicillin G potassium group:patients were instructed to apply 1 troche topically to the appointed ulcer 4 times a day (after meals and before bedtime), each troch contains 50mg of penicillin G potass

Sponsors

West China Stomatology Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 73 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 12 years or older can follow doctor's advice; 2. Willing 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

Exclusion criteria: 1. History of allergies to penicillin, cephalosporins or beta-lactamantibiotics; 2. Pregnancy and lactation (Urine hCG-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 NSAIDs, 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 systemic 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.

Design outcomes

Primary

MeasureTime frame
pain;ulcer size;

Countries

China

Contacts

Public ContactQianming Chen
qmchen@scu.edu.cn+86 028 85405251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026