Effects of mucoadhesive paste contains olive leaf extract in the treatment of Recurrent Aphthous stomatitis (RAS) compared with topical corticosteroid

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015080723542N1

Enrollment

Registered

2015-09-12

Start date

2015-09-30

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 Aphthous. Recurrent aphthous ulcer

Interventions

Intervention 1: Intervention group: mucoadhesive paste contains Olive leaf extract. Instruction of drug usage is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping.

Treatment - Drugs

Intervention group: mucoadhesive paste contains Olive leaf extract. Instruction of drug usage is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping. Evaluation and p

Positive control group:Tropical glucocorticoid (mucoadhesive paste contains triamcinolone) with the same instruction that used in interventional group.

Negative control group: mucoadhesive paste without any drug with the same instruction that used in interventional group.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: having 1-5 minor aphthous ulcer and their ulcers diameter were less than 5mm; having pain, without unusual sense of paresthesia and anesthesia; filling informed consent form for participation in this study. Exclusion criteria: having a history of drug hypersensitivity; pregnancy and breast feeding; having the history of systemic disorders or Behcet,s syndrome; receiving any other drug comprising NSAIDs or antihistamines in last 1 month; receiving any other drug for curing the ulcers from 72 hours prior the beginning the study; receiving systemic antibiotics from 2 weeks prior the beginning the study; Aphthous ulcers nearby trauma from sharp-edged teeth, broken restorations, orthodontic appliance or partial denture

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Surface of the ulcer. Timepoint: days 0, 1, 2, 5, and 7. Method of measurement: by stereological method of point counting method of cavalieri on ulcer photographs.;Pain. Timepoint: days 0, 1, 2, 5, and 7. Method of measurement: VAS ruler of pain.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zahra Heidari

Zahedan University of Medical Sciences

histology@ymail.comhistology_iri@yahoo.com+98 54 3329 4390

Outcome results

None listed

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