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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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