A clinical trial to compare the effectiveness of topical application of 5 percent Amlexanox and Low Level Laser Therapy in reducing pain among aphthous ulcer patients

Evaluation of topical application of 5 percent Amlexanox vs Low Level Laser Therapy for pain management in Recurrent Aphthous Stomatitis A Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095288

Enrollment

Registered

2025-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: K120- Recurrent oral aphthae

Interventions

Intervention1: 5% Amlexanox oral paste along with Low-level laser therapy (LLLT): Topical application of 5% Amlexanox oral paste on the ulcer by finger four times each day on one group of patients (20

Eligibility

Inclusion criteria

Inclusion criteria: New patients with clinically diagnosed case of recurrent aphthous stomatitis.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant and lactating. 2. Patients with history of dental surgery within past 2 weeks, use of orthodontic appliances or complete denture. 3. Patients with other mucosal lesions with aphthous ulcers and systemic diseases causing oral ulcerations.

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale (0-10)- To assess reduction in pain perception.Timepoint: Baseline, after 1 day, after 2 days.	—

Secondary

Measure	Time frame
To evaluate the healing of Recurrent aphthous ulcer.Timepoint: Baseline, after 1 week.	—

Countries

India

Contacts

Public ContactDr Philips Mathew

Government Dental College Kottayam

drphilipsmathew@gmail.com7907411361

Outcome results

None listed

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