临床试验/NCT04203134

NCT04203134已完成不适用

Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)

University of Florida2 个研究点分布在 1 个国家目标入组 8 人开始时间: 2020年1月15日最近更新: 2022年1月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Florida
入组人数: 8
试验地点: 2
主要终点: Effectiveness in pain control

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.

详细描述

The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for BMS.

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: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•New patients diagnosed with BMS seen in the oral medicine clinic for the study period.
•Exclusion criteria includes:
•Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis
•Inclusion Criteria:

排除标准

未提供

结局指标

主要结局

Effectiveness in pain control

时间窗: Baseline through 6 month

patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as "no pain" and 5 as "excruciating pain"

次要结局

未报告次要终点

研究者

发起方

University of Florida

申办方类型

Other

责任方

Sponsor

研究点 (2)

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