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Recruiting NCT06819033

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

Phase IV Interventional Aphthous Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PBM Therapy, Maalox plus Benadryl.
Who it may be relevant to
Registry conditions: Aphthous Ulcer. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Device PBM Therapy
    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.
  • Drug Maalox plus Benadryl
    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.

Primary outcome measures

  • Change in Quality of life as assessed by questionnaire (Likert scale) [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 outcome measures (3)
  • 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 [Time frame: Baseline, 24 hours after treatment]
  • Pain as assessed by a Visual Analogue Scale (VAS) for experimental group [Time frame: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06819033 · HSC-DB-24-1153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗