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

NCT ID: NCT06416046

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intraoral photobiomodulation (PBM)

A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm. The equipment will be programmed with 0,3W of power. The application of PBM will be carried out for at least 03 alternate days within 01 week by a trained professional. Patients who still have an ulcerated lesion on the 7th day will be assessed every 2 days until complete healing. During each irradiation, the applicator and patients will wear specific protective goggles and the instruments will be disinfected with an antiseptic solution (Chlorhexidine 2%).

Points of application:

Equidistant points (0.5cm) along the length of the lesion and in contact with the lesion.

Group Type: EXPERIMENTAL

Gemini laser

Intervention Type: DEVICE

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.

Placebo

The application of placebo will be carried out for at least 03 alternate days within 01 week (3x within 07 days) by a trained professional. Patients who still have an ulcerated lesion on the 7th day will be assessed every 2 days until complete healing. The device will not be activated and the applicator and patients will wear specific protective goggles and the instruments will be disinfected with antiseptic solution (Chlorhexidine 2%).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Examination and follow-up until the lesion heals spontaneously. The laser will not be activated.

Interventions

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.

Intervention Type: DEVICE

Placebo

Examination and follow-up until the lesion heals spontaneously. The laser will not be activated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over the age of 18
• Patients presenting at least one painful mouth ulcer (minor ulcer), located on the tongue, jugal mucosa or labial mucosa, starting on the same day or the day before.

Exclusion Criteria

• Patients who have already undergone other treatment for RAS;
• Patients with asymptomatic ulcers;
• Patient must not be undergoing or have undergone any treatment for RAS;
• Patients with any systemic condition related to RAS - e.g. Behcet's Syndrome, Periodic Fever Syndrome, Pharyngitis and Cervical Adenitis, HIV infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Manoela Domingues Martins

Principal Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manoela Martins, PhD

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Central Contacts

Manoela Martins, PhD

Role: CONTACT

manomartins@gmail.com

555133085011

Liliana Braun

Role: CONTACT

lili.wolfb@hotmail.com

5551996664438

Other Identifiers

PMB and RAS

Identifier Type: -

Identifier Source: org_study_id