Efficacy of Thai Rice-based Oral Films Containing Triamcinolone, Diclofenac, and Lidocaine for Recurrent Aphthous Stomatitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250815005

Enrollment

152

Registered

2025-08-15

Start date

2025-08-18

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patient with recurrent aphthous stomatitis recurrent aphthous stomatitis, ulcer, triamcinolone acetonide, diclofenac, lidocaine

Interventions

apply the Thai rice-based oral film to recurrent aphthous stomatitis for 7 days ,apply the Thai rice-based oral film to recurrent aphthous stomatitis for 7 days ,apply the Thai rice-based oral film

Placebo Comparator Other,Experimental Drug,Experimental Drug,Experimental Drug

Thai rice-based oral films,Thai rice-based oral films containing lidocaine ,Thai rice-based oral films containing lidocaine and triamcinolone acetonide ,Thai rice-based oral films containing lidocain

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Over 18 years of age 2.Patients who clinically present and receive a diagnosis of recurrent aphthous stomatitis, with ulcer appearing within 48 hours and having a diameter not exceeding 8 millimeters 3.Willing to participate in the treatment

Exclusion criteria

Exclusion criteria: 1.Patients has a history of hypersensitivity to any components used in the research product, such as triamcinolone acetonide, diclofenac, lidocaine, cellulose, or methylparaben. 2.Patients who have used other medicine. 3.Pregnant or lactating women. 4.Patients with oral aphthous ulcers secondary to systemic diseases. 5.Patients with oral ulcers due to bacterial, fungal, or viral infections. 6.Patients who have used steroids within the past week. 7.Patients who are eligible to use corticosteroids during the study period. 8.Patients who have used analgesics and non-steroidal anti-inflammatory drugs other than steroids within 48 hours. 9.Patients with oral ulcers resulting from trauma, accidents, or orthodontic appliance placement

Design outcomes

Primary

Measure	Time frame
size of ulcer day 1 and 7 dental probe measurement	—

Secondary

Measure	Time frame
salivary cortisol level day 1 and 7 ELISA,Thai stress test day 1 and 7 Thai stress test questionaries	—

Countries

Thailand

Contacts

Public ContactJitjiroj Ittichaicharoen

Faculty of Dentistry, Chiang Mai University

Tambodad@gmail.com053944455

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026