| CTRI Number |
CTRI/2025/09/095288 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Evaluation of topical application of 5 percent Amlexanox vs Low Level Laser Therapy for pain management in Recurrent Aphthous Stomatitis A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Prasad |
| Designation |
Postgraduate Resident |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Oral Medicine and Radiology, Room no. 601
Government Dental College, Kottayam, Gandhinagar P.O, Kottayam
Kottayam KERALA 686008 India |
| Phone |
9745775883 |
| Fax |
|
| Email |
aparnahrh7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Philips Mathew |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Oral Medicine and Radiology, Room no.601,
Government Dental College Kottayam, Gandhinagar P.O, Kottayam
Kottayam KERALA 686008 India |
| Phone |
7907411361 |
| Fax |
|
| Email |
drphilipsmathew@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Philips Mathew |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College Kottayam |
| Address |
Department of Oral Medicine and Radiology, Room no.601,
Government Dental College Kottayam, Gandhinagar P.O, Kottayam
Kottayam KERALA 686008 India |
| Phone |
7907411361 |
| Fax |
|
| Email |
drphilipsmathew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology, Room no. 601, Government Dental College Kottayam, Gandhinagar P.O, Kottayam, Kerala - 686008, India |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Prasad |
| Address |
Department of Oral Medicine and Radiology, Room no. 601
Government Dental College Kottayam
Gandhinagar P.O,
Kottayam
Kerala
686008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna Prasad |
Government Dental College Kottayam |
Department of Oral Medicine and Radiology, Room no. 601, Government Dental College Kottayam, Gandhinagar P.O, Kottayam, Kerala - 686008, India Kottayam KERALA |
9745775883
aparnahrh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee (IEC)/Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5% Amlexanox topical application. |
Topical application of 5% Amlexanox oral paste on the ulcers by taking a small amount of the paste on finger tips and applied using gentle pressure for four times a day. |
| Intervention |
Low-level Laser therapy (LLLT) |
Use of Low-level Laser therapy on the recurrent aphthous ulcer on the first visit of patient within 2 days of appearance of ulcers. The ulcer is irradiated for 8-10 seconds at a distance of 2-3mm in non-contact mode (SIROLaser Xtend diode Laser). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
New patients with clinically diagnosed case of recurrent aphthous stomatitis. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (0-10)- To assess reduction in pain perception. |
Baseline, after 1 day, after 2 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the healing of Recurrent aphthous ulcer. |
Baseline, after 1 week. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recurrent aphthous stomatitis (RAS), generally known as canker sores, is a common inflammatory condition of oral mucosa, which affects more than 20% of the population. They are characterized by painful ulcerations that may reappear at varying intervals ranging from a few days to several months and significantly affecting patient’s quality of life. Typically, the ulcers present as single or multiple rounded, shallow, painful with a greyish-white pseudomembrane encircled by an erythematous halo. They are most commonly found on non-keratinized, mobile oral mucosal surfaces. Patients suffer major difficulties in eating, drinking and maintaining oral hygiene due to severe pain from the lesion. Although, precise cause for the ulcers remain unclear, various triggering factors such as trauma, stress, hormonal imbalances, microbial infections, vitamin deficiencies and genetic predispositions are believed to contribute to their occurrence. Several treatment options are available, and they depend upon factors like disease severity (pain intensity), frequency of ulcers and side effects of prescribed medications. If an underlying condition is identified, its management can help prevent the ulcer recurrence. However, in cases where no clear case is found, treatment remains symptomatic, aiming to reduce pain, accelerate healing and prolong ulcer-free periods. Current therapeutic measures include topical and systemic steroids, topical anesthetics, cauterization, antibiotics, antiseptic mouth washes, anti-inflammatory and immune modulators. Amlexanox oral paste is an emerging treatment for aphthous ulcers, it has marked anti-inflammatory, anti-allergic and immunomodulatory effects. It inhibits the formation and release of inflammatory modulators with membrane-stabilizing effect on cellular structures. By increasing the intracellular cyclic adenosine monophosphate (cAMP) content, it inhibits the release of inflammatory mediators like histamine, tumor necrosis factor-alpha, and leukotrienes. Amlexanox prevents recurrence, reduce pain and accelerates healing thus offering a three-fold benefit in treatment of minor recurrent aphthous ulcers. Recently, low-level laser therapy (LLLT) has gained attention for its ability to enhance healing process through biomodulation, offering immediate pain relief without excessive medication usage. The therapeutic effects of low-level laser energy were first identified by Dr Endre Mester in 1967. Since then it has been widely utilized in various and dental applications and is commonly referred to as "low-level laser therapy" (LLLT), biostimulation or phototherapy. In addition to offering both time and cost advantages for patients, LLLT has been established as a safe and clinically effective therapy for aphthous ulcer management. This approach enables dentists to expand the range of treatment options in their practice while ensuring quick and comfortable symptom relief for patients. Hence, this clinical trial aims to evaluate the effectiveness of LLLT in pain relief of aphthous ulcers and to compare its outcome with those of topical application of amlexanox. |