Effects of Different Occlusal Splints on Joint Vibrations in Bruxers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device
研究概览
简要总结
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
详细描述
It was demonstrated that occlusal splints are effectual on improving clinical symptoms and reducing patient complaints in patients with bruxism. However the effects of occlusal splints on joint vibrations are not fully elucidated. The aim of this study is to evaluate the effects of three different occlusal splints (soft, hard and semi-soft) on joint vibrations in patients with bruxism and to compare with asymptomatic individuals. And also clinical symptoms and patient complaints were evaluated with questionnaire forms.
This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.
There was no significant difference in joint vibration parameters between patients with bruxism and asymptomatic individuals before treatment (p>0.0063). Between the increase in soft group and reduction respectively in hard group and semi-soft group for total integral values variations, after treatment at the opening movement for left joint were statistically significant (p=0.005 and p<0.001). Total integral, i>300 Hz, i<300 Hz, Peak amplitude, Peak frequency values of patients with bruxism were observed to be higher than the value of asymptomatic individuals, allthough there was no statistical difference. After three different occlusal splint treatment, it was observed that there was clinically improvement in patient complaints.
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, Outcomes Assessor)
盲法说明
Participants were blinded because they did not know the method of interventional treatment (occlusal splints) given to them. In addition, the outcome assessor was blinded because he assessed the patients with the occlusal splints out of their mouths. Therefore, this research had double blind study design.
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a complaint of grinding/clenching during sleep
- •One or more of the following occurs:
- •abnormal wear of the teeth
- •sounds associated with the bruxism
- •jaw muscle discomfort
- •No other medical or mental disorders that affecting masticatory muscles activity
排除标准
- •Patients with missing at least 2 posterior teeth, except for the third molars
- •Presence of Myofascial Pain Dysfunction (MPD)
- •Presence of major neurological, psychiatric or motor disorders
- •Patients using medications, influencing sleep or motor functions
- •Patients with alcohol or drug addiction
- •Patients ongoing any dental treatment
- •Patients using occlusal splint or exposing the treatment for TMJ disorders in the last 3 months.
- •Patients with pregnancy
- •Patients with cancer
- •Patients with scheduled surgery operation
- •Patients with pericoronitis or supraeruption of 3rd molar
研究组 & 干预措施
Soft Splint
It is a type of occlusal splint using soft material. It was applied to bruxist patients in accordance with the study design (Group 2).
干预措施: occlusal splint (Device)
Hard Splint
It is a type of occlusal splint using hard material. It was applied to bruxist patients in accordance with the study design (Group 3).
干预措施: occlusal splint (Device)
Semi-soft Splint
It is a type of occlusal splint using semi-soft material. They cover the advantages of soft and hard occlusal splints. It was applied to bruxist patients in accordance with the study design (Group 4).
干预措施: occlusal splint (Device)
结局指标
主要结局
Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device
时间窗: 3 days
Joint vibration analysis resulting from the movement between temporomandibular joint surfaces was performed by using a Joint Vibration Analysis device (BioPAK (BioResearch, Inc., Milwaukee, WI). Joint vibration analysis parameters were evaluated after occlusal splint treatments in patients with bruxism for each arm.
次要结局
未报告次要终点
研究者
Bora Akat
Assistant Professor
Ankara University