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NCT Number: NCT06819033

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

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.

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Key information

Conditions

Aphthous Ulcer Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBM Therapy

Device

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 Benadryl

Drug

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 outcomes

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

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

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

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

    Time frame: upto 24 hours after treatment

  3. 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

  1. 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)

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

    Time frame: Baseline, 24 hours after treatment

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

  3. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Chiquet, DDS, PhD

CONTACT

[email protected]

(713) 500-8220

Jessica Hochschuler

CONTACT

[email protected]

(713) 486-4141

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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