A Phase 4 interventional study of PBM Therapy and Maalox plus Benadryl in Aphthous Ulcer, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 30 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Device: PBM Therapy · Drug: Maalox plus Benadryl
Drug: Maalox plus Benadryl
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 page: Diphenhydramine
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.
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
Time frame: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment
Pain as assessed by how frequently patient complains of pain (Likert scale)
Time frame: 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
Time frame: upto 24 hours after treatment
Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool
Time frame: pre-treatment and immediately post-treatment(about 5 minutes)
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)
Time frame: Baseline, 24 hours after treatment
Pain as assessed by a Visual Analogue Scale (VAS) for experimental group
Pain level is scored from 0(no pain) to 10(worst pain)
Time frame: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Feb 2026, 11 months after the start.
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