Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pressure pain threshold in designated points
研究概览
简要总结
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study.
详细描述
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study. Probable bruxism will be diagnosed on the basis of the patient's history and examination as follows. Inclusion criteria:
I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
A. The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
B. One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- •A. The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- •B. One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- •C. The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
- •II. Additional questionnaire for detecting bruxers:
- •Has anyone heard you grinding your teeth at night? Is your jaw ever fatigued or sore in the morning? Are your teeth or gums ever sore on awakening in the morning? Do you ever experience temporal headaches on awakening in the morning? Are you aware of grinding your teeth during the day? Are you ever aware of clenching your teeth during the day Can you imitate a sound of grinding using your teeth.
排除标准
- •unrestored tooth losses
- •patients wearing removable dentures of any kind
- •psychiatric conditions undermining/preventing occlusal splint usage
结局指标
主要结局
Pressure pain threshold in designated points
时间窗: 30 days
Evaluation of difference between algometer readings before and after 30 days of splint usage - FPX25 algometer (Wagner instruments, US) will be used
次要结局
未报告次要终点
研究者
Dalewski Bartosz
DMD, PhD
Pomeranian Medical University Szczecin