Aphthous Ulcer
Conditions
Keywords
magic mouthwash, laser treatment
Brief summary
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.
Interventions
DEVICEPBM 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.
DRUGMaalox 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life as assessed by questionnaire (Likert scale) | Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment | 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) | upto 24 hours after treatment | — |
| 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 | upto 24 hours after treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool | pre-treatment and immediately post-treatment(about 5 minutes) | — |
| Change in pain as assessed by a Visual Analogue Scale (VAS) for control group | Baseline, 24 hours after treatment | Pain level is scored from 0(no pain) to 10(worst pain) |
| Pain as assessed by a Visual Analogue Scale (VAS) for experimental group | Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment | Pain level is scored from 0(no pain) to 10(worst pain) |
Countries
United States
Contacts
Primary ContactBrett Chiquet, DDS, PhD
Backup ContactJessica Hochschuler
Outcome results
None listed