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

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.