Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients

Phase 4RecruitingNCT06819033

The University of Texas Health Science Center, Houston30 enrolled

Overview

The purpose of this study is to compare the efficacy of laser photobiomodulation and "Magic Mouthwash" for treatment of pain in pediatric patients with aphthous ulcers , to assess how photobiomodulation influences the rate of healing of aphthous ulcers in pediatric patients and to measure changes in pain levels reported by pediatric patients undergoing photobiomodulation treatment for aphthous ulcers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aphthous Ulcer

Interventions

PBM TherapyDEVICE

patients will receive PBM therapy using the Biolase Epic pro laser. An average power of 0.6w (peak power = 80w, rep. rate= 20Hz). Each aphthous ulcer will be irradiated one time for a total of 30 seconds via continuous wave.

Maalox plus BenadrylDRUG

1:1 mixture of Maalox and Benadryl will be applied to the ulcer as needed for pain. Applications typically will be applied before eating to form a dissolvable oral band-aid that lasts for up to 30 minutes. 10 milliliters of 1:1 Maalox: Benadryl solution will be provided to the family. During the presenting appointment, the patient/family will be shown how to use the 1:1 Maalox: Benadryl solution. It will be applied topically with no rinsing needed.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient/guardian speaks either English or Spanish * Patient presenting with one or more aphthous ulcers in their mouth, identified during a scheduled dental appointment * No previous PBM treatment to the presenting aphthous ulcer(s) * Guardian able to partake in a follow-up phone call in either the English or Spanish language Exclusion Criteria: * Patient presents with aphthous ulcers recently treated with PBM * Patient presents with herpes labialis (cold sores) * Patients presents with systemic disease that affects soft tissue/mucous healing

Outcomes

Primary Outcomes

Change in Quality of life as assessed by questionnaire (Likert scale)

This is a 6 item questionnaire and each is scored from 1-5, maximum score of 30,higher number indicating better outcome

Time frame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment

Pain as assessed by how frequently patient complains of pain (Likert scale)

Time frame: upto 24 hours after treatment

Pain as assessed by number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain

Time frame: upto 24 hours after treatment

Secondary Outcomes

Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool

Time frame: pre-treatment and immediately post-treatment(about 5 minutes)

Change in pain as assessed by a Visual Analogue Scale (VAS) for control group

Pain level is scored from 0(no pain) to 10(worst pain)

Time frame: Baseline, 24 hours after treatment

Pain as assessed by a Visual Analogue Scale (VAS) for experimental group