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

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Aphthous Ulcer

Treatments: Drug: Maalox plus Benadryl; Device: PBM Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06819033

HSC-DB-24-1153

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

PBM Therapy

Experimental group

Treatment:

Device: PBM Therapy

Drug: Maalox plus Benadryl

Standard of care

Active Comparator group

Treatment:

Drug: Maalox plus Benadryl