Comparison of five doses of mucoadhesive prednisolone in treatment of recurrent aphthous stomatitis

Comparison of five doses of mucoadhesive prednisolone (0.5, 1, 2.5, 5, 10mg) in treatment of recurrent aphthous stomatitis: A Triple blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110037710N1

Enrollment

225

Registered

2012-07-22

Start date

2012-12-21

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 Aphthous Stomatitis. Stomatitis and related lesions

Interventions

Intervention 1: 3rd group : Intervention : the patients will put mucoadhesive prednisolone 2.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days. Inter

Treatment - Drugs

3rd group : Intervention : the patients will put mucoadhesive prednisolone 2.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.

1st group : Intervention : the patients will put mucoadhesive prednisolone 0.5 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.

2nd group : Intervention : the patients will put mucoadhesive prednisolone 1.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.

4th group : Intervention : the patients will put mucoadhesive prednisolone 5.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.

5th group : Intervention : the patients will put mucoadhesive prednisolone 10.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: People aged 18-45 years; at least 3 months presentation of RAS; at least 1 breakout of disease each month; not responding to any medication. Exclusion criteria: systemic disease such as: diabetes, liver disease, Gastro-intestinal disease, kidney disease, Rheumatologic disease or behcet syndrome; people with teched CBC lab data; patients who take immunosupressive / immunomodulant medicine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Number of ulcers. Timepoint: before intervention and then every 24 hour for 6 days. Method of measurement: observation.;Size of ulcers. Timepoint: before intervention and then every 24 hour for 7 days. Method of measurement: with caliper.;Severity of pain and burning sensation. Timepoint: before intervention and then every 24 hour for 7 days. Method of measurement: Visual Analogue Scale Score.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Farzad Gheshlaghi

Isfahan University of Medical Sciences

gheshlaghi@med.mui.ac.ir+98 31 1669 7823

Outcome results

None listed

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