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

NCT06416046 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PMB and RAS
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Photobiomodulation; Stomatitis, Aphthous

Outcome Measures

Primary Outcomes (3)

• Pain assessment

  Pain will be assessed at all appointments using the Visual Analog Scale (VAS), which will be represented by a 10 cm straight line, where 0 corresponds to the best situation and 10 to the worst situation. The research subjects will be instructed by the evaluator to mark a point on the 10 cm line.

  1 week

• Assessment of ulcer size

  Ulcer size will be assessed at every appointment using the tip of a millimeter-sized periodontal probe.

  1 week

• Functional assessment

  The functional assessment will be carried out at all appointments, evaluating the patient's subjective experience of difficulty in eating, drinking and brushing their teeth due to the presence of RAS. The answers will be scored from 0 (no difficulty) to 4 (a lot of difficulty) according to the questionnaire given to the patients

  1 week

Secondary Outcomes (2)

• Time measurement

  1 week

• Saliva collection

  1 week

Study Arms (2)

Intraoral photobiomodulation (PBM)

EXPERIMENTAL

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.

Device: Gemini laser

Placebo

PLACEBO COMPARATOR

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%).

Other: Placebo

Interventions

Gemini laser 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.

Intraoral photobiomodulation (PBM)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Manoela Martins, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Manoela Martins, PhD

CONTACT

555133085011; manomartins@gmail.com

Liliana Braun

CONTACT

5551996664438; lili.wolfb@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, examiner and outcomes assessor will not know which group has been allocated (triple-blind). Another person (the applicator) will carry out the randomization and know which group the patient belongs to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Professor

Model Details: Participants will be allocated and randomized into 2 groups: Group I: PBM (n=17) photobiomodulation intra oral high potency laser (4.5J) and Group II: control (n=17).

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the outcomes, for one year
• Access Criteria: If formally requested and referenced by the interested researcher