The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- occlusal force
研究概览
简要总结
Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.
In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.
详细描述
Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.
Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.
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
- Double (Participant, Investigator)
盲法说明
Blinding the participants and investigator to the splint types employed in patients
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy participants with complete permanent dentition.
排除标准
- •Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
- •Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
- •Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
- •Tooth loss (except for third molars),
- •Soft tissue abnormalities,
- •Toothache report,
- •Active periodontitis (presence of periodontal pockets involvement of the supporting tissues),
- •Caries lesions,
- •Use of orthodontic appliances,
- •Use of dental prosthesis (fixed or removable partial).
- •Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment)
- •Alcohol or drug abuse,
结局指标
主要结局
occlusal force
时间窗: 2 months
Measuring maximum occlusal force by using digital gnatodynanometer
Sleep quality
时间窗: 2 months
Evaluating sleep quality with Pittsburgh sleep quality index
次要结局
未报告次要终点
研究者
Dr. Merve Benli
Assistant Professor
University of Pittsburgh