Идёт набор NCT06819033

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

Фаза IV С лечением Aphthous Ulcer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PBM Therapy, Maalox plus Benadryl.
Кому может быть актуально: Состояния в реестре: Aphthous Ulcer. Базовые параметры: 5 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Устройство 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.
Препарат 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.

Первичные конечные точки

Change in Quality of life as assessed by questionnaire (Likert scale) [Срок оценки: Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment]
Pain as assessed by how frequently patient complains of pain (Likert scale) [Срок оценки: 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 [Срок оценки: upto 24 hours after treatment]

Вторичные конечные точки (3)

Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool [Срок оценки: pre-treatment and immediately post-treatment(about 5 minutes)]
Change in pain as assessed by a Visual Analogue Scale (VAS) for control group [Срок оценки: Baseline, 24 hours after treatment]
Pain as assessed by a Visual Analogue Scale (VAS) for experimental group [Срок оценки: Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment]

Критерии участия

Критерии включения

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