Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Total Number of Nights of Splint Wear for Four Months Per Subject.
研究概览
简要总结
Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials.
Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction.
Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.
详细描述
Subjects. Sample size estimations are based upon a recent review of randomized clinical trials, in which acrylic appliances were evaluated (see Appendix 2 in (Huynh et al., 2007)). The mean +/- 1 standard deviation (SD) number of bruxism episodes per hour with a Michigan bite splint was 3.97 + 0.58, and for a palatal splint, the mean +/- 1 SD was 4.45 + 0.63. Using these means and the higher SD (0.63), along with an alpha = 0.05 and beta = 0.8, a study would be sufficiently powered with sample sizes of 29 per group. Based on other Michigan studies, wherein recruitment, exclusion and attrition rates are known, it is estimated that an initial screening sample size of 120 will be necessary to end up with 29 per group.
There will be two treatment groups: a group receiving supervised training in the fabrication of the SOVA night guard (SOVA) and a group receiving the Michigan custom-acrylic bite splint (MI BS). Two groups times 29 subjects per group equals 58 total needed for analysis.
Care will be taken to match the randomized groups for age, ethnicity, gender and temporomandibular disorders (TMD) signs/symptoms. Alternatively these will be modeled as nuisance variables if attrition rates create bias or there is a lack of sufficiently sized screening pools.
Screening. Candidates will undergo a screening to assess co-morbidities and to identify inclusion and exclusion criteria. Standard questionnaires and screening instruments and a brief clinical exam will be performed. Subjects meeting the acceptance criteria will be randomly assigned to one of the two groups using stratified randomization procedures (Suresh, 2011). Alginate impressions will be taken, and impressions poured in stone. The models will be used either to fabricate the MI BS or to assess SOVA appliances for fabrication efficacy.
Splint delivery. For the SOVA group, subjects will be asked to fabricate SOVA devices in the clinical laboratory while receiving feedback from trained and calibrated study 'instructors'. Fabrication will use manufacturer instructions. Calibrated instructors will be blinded to the study's objectives, as will subjects. A "Michigan" acrylic bite splint will be fabricated using standard clinical practice and checked for fit and quality on subjects assigned to the MI BS group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tooth wear
- •Night time grinding and clenching noises
- •Full dentition sans 3rd molars
- •Ability to follow instructions
- •Ability to report to the clinical laboratory at appointed times over the course of the study.
- •Exclusion Criteria
- •Decayed, missing teeth
- •Cardiovascular disease
- •Sleep apnea, sleep disorders, movement disorders
- •Active orthodontics
- •Periodontal disease
- •Partial or full dentures
- •Medications with movement disorders as side effects
排除标准
- 未提供
研究组 & 干预措施
SOVA bite splint
SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.
干预措施: SOVA Bite Splint (Device)
Michigan Bite Splint
Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.
干预措施: Michigan Bite Splint (Device)
结局指标
主要结局
Total Number of Nights of Splint Wear for Four Months Per Subject.
时间窗: 4 months
Count of the total number of entire nights that subjects wore the splint provided to them in the study.
次要结局
- Number of Bruxing Events Per Hour Sleep Per Night.(4 months)
- Compliance -- Use of Alternative Devices(4 months)
- Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation(4 months)
- User Satisfaction -- Ease of Fabrication(On day of delivery)
- Functional Efficacy -- Tooth Wear(4 months)
- Fabrication Efficacy -- Retention Trials Week 1(1 week)
- Fabrication Efficacy -- Retention Trials, Month 4(4 months)
- Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation(Day of delivery)
- User Satisfaction -- Self-Report of Splint Fit(4 months)
- Splint Material Loss / 4 Months.(4 months)
- Compliance -- Appliance Removal at Night(4 months)
- Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism(4 months)
- User Satisfaction -- Ease of Instructions(On day of delivery)
- Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness(Day of Delivery)
- Fabrication Efficacy -- Oral Health Plaque Index(1 week and 4 months)
- Fabrication Efficacy -- Oral Health Modified Gingival Index(1 week and 4 months)
- Stability -- Splint Movement During Jaw Movement Tasks(4 months)
- Fabrication Efficacy -- Estimated Bite Forces During Stability Testing(4 months)
- Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation(Day of Delivery)
- Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material(Day of Delivery)
- Stability -- Number of Splints Dislodged by Clenching(4 months)
- Stability -- Number of Splints Dislodged by Grinding(4 Months)
- Stability -- Number of Splints Dislodged by Tapping(4 months)
- Stability -- Number of Splints Dislodged During Border Movement Trials(4 months)
- Stability -- Number of Splints Dislodged During Maximum Openings(4 Months)
研究者
Geoffrey E. Gerstner
Associate Professor
University of Michigan