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临床试验/CTRI/2024/07/071578
CTRI/2024/07/071578尚未招募不适用

Comparison of the efficacy and comfort of oral appliances by change in vertical dimension for symptomatic relief in individuals with non-apneic snoring and three-dimensional evaluation of the changes created in the upper pharyngeal airway using Cone-Beam Computed Tomography - A randomized controlled crossover trial

Aayushi Chauhan1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
Epworth sleepiness scale score,

研究概览

简要总结

A literature search indicates that since 1985 approximately 150 articles that describe various oral devices used in the treatment of sleep disorders have been published. The majority of these studies represent case series or case reports and a much smaller number are randomized controlled trials. It is generally accepted that treatment of OSA with oral appliances is a viable option for some patients with varying degrees of short- and long-term improvement and side effects. Oral appliance treatment includes, in order of decreasing usage, adjustable and nonadjustable mandibular posturing devices, anterior tongue positioners, and soft palate or uvula lifting devices. An appliance that advances the tongue, or tongue and mandible together with adjacent soft tissue, increases the posterior airway space, increases the activity of the genioglossal and lateral pterygoid muscles. It is not yet possible to predict the most advantageous appliance type for a particular patient. There are conflicting data regarding the effect of the degree of bite opening (vertical dimension of opening [VDO]) induced by oral appliances on treatment outcome. Although some studies have shown that appliances that promote an increased VDO are effective, physiologic evidence suggests that the VDO should be kept to a minimum to optimize treatment outcome. In this study, the efficacy of the of an oral appliance with minimum VDO will be tested against an appliance that increases VDO (such as twin block) based on the Epworth Sleepiness scale, Decibel readings, overall comfort of appliance for the patient, any potential side effects of either appliance. Furthermore, Computed tomographs will be taken to see the effect of the two appliances on the upper airway space of the patient with non-apnoeic snoring.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Snorer No missing teeth.

排除标准

  • Periodontal disease
  • Edentulous
  • Nasal congestion / obstruction
  • Patient on sedatives
  • Epileptic or mentally challenged patients
  • Temporomandibular joint pain/clicking
  • Patients with any neuromuscular disorder 8.

结局指标

主要结局

Epworth sleepiness scale score,

时间窗: Ewporth Sleepiness scale score to be assessed after 2 weeks | Decibel recordings will be taken daily for 2 weeks after appliance delivery | Volumetric airway measurement will be done using cbct on the day of appliance delivery

Decibel recording,

时间窗: Ewporth Sleepiness scale score to be assessed after 2 weeks | Decibel recordings will be taken daily for 2 weeks after appliance delivery | Volumetric airway measurement will be done using cbct on the day of appliance delivery

Volumetric airway measurement

时间窗: Ewporth Sleepiness scale score to be assessed after 2 weeks | Decibel recordings will be taken daily for 2 weeks after appliance delivery | Volumetric airway measurement will be done using cbct on the day of appliance delivery

次要结局

  • Patient will be asked if appliance was comfortable for wear in a YES NO format(after 2 weeks of appliance wear)

研究者

发起方
Aayushi Chauhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aayushi Chauhan

Government dental college and hospital Aurangabad

研究点 (1)

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