Recruiting

Photobiomodulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06819033

Conditions

Aphthous Ulcer

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

PBM Therapy

Maalox plus Benadryl

Study Details

Brief summary:

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.

Conditions

Aphthous Ulcer

Study ID

NCT06819033

Start date

Mar 10, 2025

Status verified date

Mar, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PBM Therapy

active comparator: Standard of care

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brett Chiquet, DDS, PhD

(713) 500-8220Brett.T.Chiquet@uth.tmc.edu

Jessica Hochschuler

(713) 486-4141Jessica.L.Hochschuler@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Brett Chiquet, DDS, PhD

713-500-8220Brett.T.Chiquet@uth.tmc.edu

Jessica Hochschuler

(713) 486-4141Jessica.L.Hochschuler@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Keywords

  • magic mouthwash
  • laser treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-03-25.