Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416046
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-08
Brief Title:
Efficacy of Photobiomodulation in the Treatment and Relief of Pain in Recurrent Aphthous Stomatitis
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Behcets 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 45J 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 Behçets 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 180 software Initially data distribution will be assessed using Shapiro-Wilk and Kolmogorov-Smirnov tests If the data show normal distribution p005 the t-test will be used If the distribution is non-normal p005 the Wilcoxon test will be employed The significance level p-value will be set at 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None