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

Conditions

• Aphthous Ulcer

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Mar 10, 2025

Status verified

Mar 2025

Primary completion

Feb 27, 2026

Completion

Feb 28, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PBM Therapy
• Active Comparator: Standard of care

Primary Outcome Measure

Change in Quality of life as assessed by questionnaire (Likert scale) [ Time Frame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment ]

Central Contacts

• Brett Chiquet, DDS, PhD
  (713) 500-8220
  [email protected]
• Jessica Hochschuler
  (713) 486-4141
  [email protected]

Locations (1)

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