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

NCT06819033 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: HSC-DB-24-1153
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

magic mouthwash; laser treatment

Outcome Measures

Primary Outcomes (3)

• 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

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

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

  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

  upto 24 hours after treatment

Secondary Outcomes (3)

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

  pre-treatment and immediately post-treatment(about 5 minutes)

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

  Baseline, 24 hours after treatment

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

  Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment

Study Arms (2)

PBM Therapy

EXPERIMENTAL

Device: PBM Therapy; Drug: Maalox plus Benadryl

Standard of care

ACTIVE COMPARATOR

Drug: Maalox plus Benadryl

Interventions

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.

PBM Therapy

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.

PBM Therapy; Standard of care

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Low-Level Light Therapy; aluminum hydroxide, magnesium hydroxide, drug combination; Diphenhydramine

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Brett Chiquet, DDS, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett Chiquet, DDS, PhD

CONTACT

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

Jessica Hochschuler

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: March 10, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 28, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)