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临床试验/NCT05553860
NCT05553860已完成不适用

Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances

University of Alberta1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Apnea-hypopnea index (AHI)

研究概览

简要总结

This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

详细描述

Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient diagnosed with obstructive sleep apnea, and
  • Prescription/order for a dental sleep appliance
  • 18 years or older
  • Treatment planned in accordance with AADSM treatment guidelines

排除标准

  • There are no separate exclusion criteria

研究组 & 干预措施

Anterior Protrusive

Active Comparator

use of anterior protrusive positioning technique

干预措施: Speech positioning technique (Other)

Speech Position

Experimental

use of speech positioning technique

干预措施: Speech positioning technique (Other)

结局指标

主要结局

Apnea-hypopnea index (AHI)

时间窗: 3 months

Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea

次要结局

  • Overjet(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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