Actively Recruiting
Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
Led by The University of Texas Health Science Center, Houston · Updated on 2025-03-25
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of laser photobiomodulation (PBM) and a topical mixture known as "Magic Mouthwash" for reducing pain in children with aphthous ulcers, which are painful sores in the mouth. The study also seeks to understand how PBM affects the healing speed of these ulcers and to track changes in pain levels reported by pediatric patients receiving PBM treatment. Participants will be randomly assigned to one of two groups: one receiving PBM therapy using the Biolase Epic pro laser, which applies light treatment for 30 seconds to each ulcer, and the other receiving a 1:1 mixture of Maalox and Benadryl applied topically as needed to relieve pain before eating. Families will be instructed on how to use the Maalox-Benadryl solution, which forms a dissolvable protective layer lasting up to 30 minutes. Throughout the study, participants will be assessed for changes in quality of life and pain levels using questionnaires and pain scales at baseline, immediately after treatment, and 24 hours later. Researchers will also evaluate changes in ulcer size through clinical images taken before and after treatment. Monitoring includes tracking pain frequency and use of any over-the-counter or prescription pain medications. The study involves follow-up phone calls in English or Spanish to support ongoing assessment of healing and pain.
CONDITIONS
Brief Title
Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian speaks English or Spanish
- Patient has one or more aphthous ulcers in the mouth identified during a scheduled dental appointment
- No previous photobiomodulation treatment to the presenting aphthous ulcer(s)
- Guardian can participate in follow-up phone calls in English or Spanish
You will not qualify if you...
- Patient has had recent photobiomodulation treatment to aphthous ulcers
- Patient has herpes labialis (cold sores)
- Patient has systemic disease affecting soft tissue or mucous healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event with assessments up to 24 hours afterward
Participants receive either photobiomodulation (PBM) therapy applied once to each aphthous ulcer or standard topical treatment with a Maalox and Benadryl mixture applied as needed for pain relief.
1 baseline visit and 1 follow-up visit within 24 hours
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Brett Chiquet, DDS, PhD
J
Jessica Hochschuler
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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