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

Purpose

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.

Condition

  • Aphthous Ulcer

Eligibility

Eligible Ages
Between 5 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Brett Chiquet, DDS, PhD
713-500-8220
Brett.T.Chiquet@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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