Evaluation of the Chewing Performance and Nutritional Status of the Patients Diagnosed With Bruxism After Botulinum Toxin Application: Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in the masticatory performance at 6 months
研究概览
简要总结
This study aimed to evaluate the effect of botulinum toxin type A (BTX-A) injection on masticatory performance and nutritional status in temporomandibular disorder patients with bruxism caused by both intra-articular and extra-articular pathologies based on Research Diagnostic Criteria for temporomandibular disorders (TMD). The baseline and end masticatory performance, pain intensity, nutrition and anxiety statuses, and anthropometric measurements will be compared.
详细描述
The main purpose of this study is to determine the effect of BTX-A injection on masticatory performance and nutritional status in TMD patients with bruxism.
Sub-objectives of the study;
Determination of the effect of BTX-A on masticatory performance Determination of the effect of BTX-A on pain intensity Determination of the effect of BTX-A on anthropometric measurements Determination of the effect of BTX-A on nutritional status Determination of the effect of BTX-A on anxiety status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 50 years old,
- •Male or female,
- •Able to communicate
- •Able to read and write
- •Volunteer to participate in the study,
- •At least 3 months of splint treatment and no results
- •Having Class 1 molar occlusion and not using removable prostheses
- •Marmara University, Faculty of Medicine, Department of Oral and Maxillofacial Surgery, patients diagnosed with bruxism or myofascial pain in masticatory muscles will be included in the study.
排除标准
- •Sensitivity to botulinum toxin,
- •Have received botox treatment in the last 6 months,
- •Injection site infection
- •Pregnant or lactating women
- •Those with diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease,
- •Those who do not want to sign the consent form,
- •Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.
结局指标
主要结局
Change from baseline in the masticatory performance at 6 months
时间窗: 6 months
The masticatory performance of patients at the baseline, 1 month and 6 months later will be taken with a color-changeable gum, called "XYLITOL", (70x20x1 mm 3 g; Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan). Color changeable gum was first developed specifically to evaluate a person's masticatory performance; and it changes color as it is chewed. The gum will be chewed 60 times by the TMD patients. These values will be recorded and compared with the baseline, 1 month and 6 months later. After chewing, the gum colour will be evaluated according to the improved colour scale. Colour scale ranges from 1-10, and the masticatory performance will be evaluated as poor (1-6), normal (7-8), or good (9-10) with the improved color scale.
Change from baseline in the nutritional status at 6 months
时间窗: 6 months
The nutritional status of patients at the baseline, 1 month, and 6 months later will be taken with 24-hour recall method. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)" and the amount of energy, carbohydrates, protein, fat and fiber consumed by participants will be calculated. Intake of energy, macro nutrients and fiber will be compared with the baseline, 1 month and 6 months later.
Change from baseline in the BMI at 6 months
时间窗: 6 months
The body weight (kg) and height (m) of the patients at the baseline, and 6 months later will be taken by the researcher and noted in their files. The height of patients will be taken using a stadiometer with the nearest 0.1 cm, while each participant is standing erect against the wall with heels together touching the wall, without shoes. Body composition will be analyzed by Tanita DC-360 (Accurate Technology Co., Ltd. Tianjin, China) according to the standard procedure, and the body weight, percentage of body lean mass, and fat of the participants will be recorded. Body mass index (BMI) will be calculated using weight (in kilograms) divided by the height squared (in square meters).
次要结局
- Change from baseline in the anxiety status at 6 months(6 months)
- Change in chewing ability(6 months)
- Change in pain intensity(6 months)
研究者
Ferit Bayram
Assist. Prof.
Marmara University