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

March 20, 2025 updated by: Brett Thomas Chiquet, The University of Texas Health Science Center, Houston

Effects of Photobiomodulation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
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.
Experimental: PBM Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
upto 24 hours after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 level is scored from 0(no pain) to 10(worst pain)
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
Pain level is scored from 0(no pain) to 10(worst pain)
Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Brett Chiquet, DDS, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-24-1153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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