NCT06416046

Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis

Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis: a Randomized, Triple-blind, Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Photobiomodulation (PBM) is a therapy that stimulates repair, pain relief, and reduces inflammation. The aim of this study is to evaluate the effectiveness of a new PBM protocol in the treatment and pain relief of RAS lesions.

Detailed description

Recurrent aphthous stomatitis (RAS) is the most common chronic ulcerative inflammatory disorder of the oral cavity, affecting approximately 20% of the general population, with no gender predilection. Its etiopathogenesis remains undefined, although factors such as local trauma and syndromes like Behcet's syndrome are implicated in predisposition. RAS manifests in three distinct clinical presentations, with the smallest being the most common, accounting for 80% of cases. Minor RAS present as round or oval ulcers, smaller than 1 cm, covered by a grayish-white pseudomembrane, commonly occurring on non-keratinized mucosa such as lips, buccal mucosa, and floor of the mouth. Photobiomodulation (PBM) is a therapy that stimulates repair, pain relief, and reduces inflammation. The aim of this study is to evaluate the effectiveness of a new PBM protocol in the treatment and pain relief of RAS lesions. The study is a randomized, triple-blind, placebo-controlled clinical trial to be conducted at the Hospital de Clinicas de Porto Alegre (HCPA) in Rio Grande do Sul, from March 2023 to December 2025. Thirty-four patients of both genders will be selected and randomly allocated into three groups: 17 patients in the PBM treatment group with 4.5J and 17 patients in the control group. Inclusion criteria are patients over 18 years old with at least one painful ulcer in the mouth. If the patient has more than one ulcer, all will be treated. Exclusion criteria include patients who have undergone previous treatment for RAS, patients with asymptomatic ulcers, and patients with any systemic condition related to RAS - for example, Behçet's Syndrome, Periodic Fever Syndrome, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis, HIV infection. The study outcome is lesion healing, and the independent variables analyzed in the study will be: pain, lesion size, and difficulty in eating, drinking, and brushing teeth due to the presence of RAS. These variables will be collected through questionnaires administered during all patient visits. Analyses will be performed using PASW 18.0 software. Initially, data distribution will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests. If the data show normal distribution (p\>0.05), the t-test will be used. If the distribution is non-normal (p\<0.05), the Wilcoxon test will be employed. The significance level (p-value) will be set at 5%.

Conditions

• Photobiomodulation
• Stomatitis, Aphthous

Interventions

Type	Name	Description
DEVICE	Gemini laser	Photobiomodulation (810 + 980 nm, 15s/point, 11.8J/cm²) to evaluate healing and pain relief in recurrent aphthous stomatitis. A 0.7mm intraoral tip will be used - spot 0.38cm2 on the extent of the lesion.
OTHER	Placebo	Examination and follow-up until the lesion heals spontaneously. The laser will not be activated.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-10-30
• Completion: 2025-12-30
• First posted: 2024-05-16
• Last updated: 2024-05-16

Regulatory

• FDA-regulated device study