Evaluation of topical penicillin 6.3.3 Powder in treatment of Oral aphthous ulceration

Clinical trial of comparative topical penicillin 6.3.3 powder and placebo in the treatment of patients 15 -45 years old with aphtous ulcer of mouth.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201106102154N2

Enrollment

Registered

2012-11-05

Start date

2011-05-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Recurrent oral aphthae. Recurrent oral aphthae

Interventions

Intervention 1: Drug: 0.2 mg Penicillin 6.3.3 powder, locally, with applicator, four times. Intervention 2: Placebo: 0.2 mg fiber clear powder, locally, with applicator, four times.

Treatment - Drugs

Placebo

Drug: 0.2 mg Penicillin 6.3.3 powder, locally, with applicator, four times

Placebo: 0.2 mg fiber clear powder, locally, with applicator, four times

Eligibility

Sex/Gender

All

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 15-45 years; history of oral aphthous; available sites; such as cheek mucosa, floor of mouth, lips and tongue is; attend and complete a consent form. Exclusion criteria: history of allergy to penicillin & cephalosporin or antibiotics beta Latham, improve spontaneously of ulcer less than 5 days, debilitating disease such as active tuberculosis or HIV; tobacco or alcohol abuse; Pregnancy; more than 5 ulcer in mouth; improve of ulcer less than 5 days.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Aphtous size. Timepoint: Days of zero, 3, 6, 8. Method of measurement: The largest and smallest lesion diameter was measured with a small ruler, multiply and is used to evaluate the wound.;Pain. Timepoint: Days of zero, 3 , 6 , 8. Method of measurement: Mild: Can you eat food, moderate: be able to eat more than half the food, Severe: Can not eat more than half of food.;Complications. Timepoint: Days of zero, 3, 6, 8. Method of measurement: Examination: Burning, pain, erythematic, inflammation.;Recovery period. Timepoint: Days of zero, 3, 6, 8. Method of measurement: Reduction of size and pain.	—

Measure

Time frame

Aphtous size. Timepoint: Days of zero, 3, 6, 8. Method of measurement: The largest and smallest lesion diameter was measured with a small ruler, multiply and is used to evaluate the wound.;Pain. Timepoint: Days of zero, 3 , 6 , 8. Method of measurement: Mild: Can you eat food, moderate: be able to eat more than half the food, Severe: Can not eat more than half of food.;Complications. Timepoint: Days of zero, 3, 6, 8. Method of measurement: Examination: Burning, pain, erythematic, inflammation.;Recovery period. Timepoint: Days of zero, 3, 6, 8. Method of measurement: Reduction of size and pain.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboobah Mirzadeh

Shahid Sadoughi Hospital, Shahid Sadoughi University Of Medical Sciences

dr mmirzadeh@ gmail.com+98 35 1822 4000

Outcome results

None listed

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