About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
PBM Therapy
Devicepatients 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
Drug1:1 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Quality of life as assessed by questionnaire (Likert scale)
This is a 6 item questionnaire and each is scored from 1-5, maximum score of 30,higher number indicating better outcome
Pain as assessed by how frequently patient complains of pain (Likert scale)
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
Secondary outcomes
Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool
Change in pain as assessed by a Visual Analogue Scale (VAS) for control group
Pain level is scored from 0(no pain) to 10(worst pain)
Pain as assessed by a Visual Analogue Scale (VAS) for experimental group
Pain level is scored from 0(no pain) to 10(worst pain)
Sponsors and contacts
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