Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Quality of life as assessed by questionnaire (Likert scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PBM Therapy
干预措施: PBM Therapy (Device)
PBM Therapy
干预措施: Maalox plus Benadryl (Drug)
Standard of care
干预措施: Maalox plus Benadryl (Drug)
结局指标
主要结局
Change in Quality of life as assessed by questionnaire (Likert scale)
时间窗: 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 number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain
时间窗: upto 24 hours after treatment
Pain as assessed by how frequently patient complains of pain (Likert scale)
时间窗: upto 24 hours after treatment
次要结局
- 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 as assessed by a Visual Analogue Scale (VAS) for experimental group(Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment)
研究者
Brett Thomas Chiquet
Associate Professor
The University of Texas Health Science Center, Houston