Side Effects of the Use of the Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea on Dental Occlusion and Masticatory Function
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in masticatory perfomance at 24 months
研究概览
简要总结
This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.
52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.
Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.
详细描述
This prospective observational non-randomized clinical study aims to assess the effect of use MAD on masticatory performance. 52 subjects diagnosed with OSA will participate in this study divided into two different groups: 26 treated with MAD and 26 treated with CPAP. Data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. The intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. Other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. Artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of MAD after 3 months of treatment. The main variable to be studied will be the median particle size of silicone tablets from Optozeta's test. This test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. The greater of grinded silicone, the greater of chewing performance. Another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. Degree of mixing of two colours of the gum will be checked after 40 chewing cycles. The more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. A CPAP group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with OSA by polisomnography (IAH>15).
排除标准
- •Be treated with MAD or CPAP during more than 3 months in the lasts 5 years.
结局指标
主要结局
Change in masticatory perfomance at 24 months
时间窗: Before treatment and 24 months after treatment
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation \[Qw (X) = 1 - 2E-(X/ X50)b\], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 24 months after treatment.
Change in masticatory perfomance at 6 months
时间窗: Before treatment and 6 months after treatment
The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation \[Qw (X) = 1 - 2E-(X/ X50)b\], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 6 months after treatment.
次要结局
- Change in masticatory mixing ability at 24 months(Before treatment and 24 months after treatment)
- Change in jaw functional limitation.at 6 months(Before treatment and 6 months after treatment)
- Change in jaw functional limitation.at 24 months(Before treatment and 24 months after treatment)
- Change in masticatory rhythm at 24 months(Before treatment and 24 months after treatment)
- Change in masticatory laterality at 24 months(Before treatment and 24 months after treatment)
- Change in the degree of satisfaction in masticatory function at 6 months(Before treatment and 6 months after treatment)
- Change in masticatory rhythm at 6 months(Before treatment and 6 months after treatment)
- Change in masticatory side-switch frequency at 6 months(Before treatment and 6 months after treatment)
- Change in dental mobility at 6 months(Before treatment and 6 months after treatment)
- Change in occlusal contact area at 24 months(Before treatment and 24 months after treatment)
- Change in the degree of satisfaction in masticatory function at 24 months(Before treatment and 24 months after treatment)
- Change in chewing ability at 6 months(Before treatment and 6 months after treatment)
- Change in chewing ability at 24 months(Before treatment and 24 months after treatment)
- Change in masticatory side-switch frequency at 24 months(Before treatment and 24 months after treatment)
- Change in overjet at 24 months(Before treatment and 24 months after treatment)
- Change in bite force at 6 months(Before treatment and 6 months after treatment)
- Change in dental mobility at 24 months(Before treatment and 24 months after treatment)
- Change in masticatory mixing ability at 6 months(Before treatment and 6 months after treatment)
- Change in overjet at 6 months(Before treatment and 6 months after treatment)
- Change in overbite at 6 months(Before treatment and 6 months after treatment)
- Change in occlusal contact area at 6 months(Before treatment and 6 months after treatment)
- Change in overbite at 24 months(Before treatment and 24 months after treatment)
- Change in masticatory laterality at 6 months(Before treatment and 6 months after treatment)
- Change in bite force at 24 months(Before treatment and 24 months after treatment)
研究者
Jordi Martinez-Gomis
Associate Professor
University of Barcelona