Evaluation of the Efficacy of Botulinum Toxin and Marjoram Oil Applications in Sleep Bruxism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of Changes in Bruxism Symptoms with scales (Subject Global Aesthetic Improvement Scale)
研究概览
简要总结
Objective: Bruxism is defined as clenching or grinding teeth unconsciously. It can be categorized under two subheadings: sleep and awake bruxism. This study aims to investigate the effectiveness of botox applications, a current approach in the treatment of sleep bruxism, and to evaluate the effectiveness of alternative therapies like aromatherapeutic oils. The study will compare and assess the efficacy of these methods.
Materials and Methods: This prospective study will be conducted between March 2024 and January 2025 at Bezmialem Vakıf University, Faculty of Dentistry, Department of Oral and Maxillofacial Radiology, with patients aged between 18 and 60 who have presented complaints of clenching/grinding teeth, sleep bruxism, jaw, neck, or face pain, and insomnia. The patients diagnosed with sleep bruxism will be divided into two groups, each consisting of 15 patients. The first group will include 15 patients with sleep bruxism who will receive botulinum toxin-A (BTX-A) injections, and the second group will consist of 15 patients who will use marjoram oil as an alternative treatment. Ultrasound imaging will assess the thickness and stiffness of the masseter muscle before treatment, and at 1 and 3 months post-treatment. Clinical evaluations will also be performed before treatment, and at 1 and 3 months post-treatment using scoring systems.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported teeth clenching or grinding
- •Tenderness or fatigue in the masticatory muscles upon palpation
- •Increased morning muscle pain
- •Localized myofascial pain in the jaw, face, or neck region
- •Irregular or excessive enamel wear consistent with bruxism
- •Grinding sounds during sleep confirmed by a partner
- •Morning jaw muscle stiffness and spasms causing sleep disturbances
- •Individuals older than 18 years,
- •Individuals younger than 60 years,
- •Provided informed voluntary consent
排除标准
- •Botulinum toxin injection into the masseter muscle within the last 6 months
- •Use of night guards
- •Pathology or history of surgery involving the masseter muscle or parotid gland
- •Benign or malignant tumors in the mandibular region
- •History of alcohol or substance abuse
- •Age below 18 or above 60
- •Pregnancy, postpartum period, or breastfeeding
- •Infection or dermatological lesions at the injection site
- •Diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
- •Known allergy or skin reaction to botulinum toxin A or essential oils used in aromatherapy
- •Use of muscle relaxants or other medications that may affect muscle function
研究组 & 干预措施
Botox group
Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A.
干预措施: Botox administration (Procedure)
Botox group
Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A.
干预措施: Clinical evaluation (Procedure)
Botox group
Group 1 will consist of patients with bruxism complaints who are indicated for botox treatment and will receive BTX-A.
干预措施: Imaging Time (Procedure)
aromatherapy group
Group 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil)
干预措施: Aromatherapy (Procedure)
aromatherapy group
Group 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil)
干预措施: Clinical evaluation (Procedure)
aromatherapy group
Group 2 will consist of patients with bruxism complaints and will receive Origanum Majorana (marjoram oil)
干预措施: Imaging Time (Procedure)
结局指标
主要结局
Evaluation of Changes in Bruxism Symptoms with scales (Subject Global Aesthetic Improvement Scale)
时间窗: From enrollment to the 3-month follow-up after the procedure.
It is a scoring system between 0 and 4. A score of 0 indicates that the condition is worse than before the procedure, while a score of 4 indicates an ideal outcome.
Evaluation of Changes in Bruxism Symptoms with scales (The Fonseca Anamnestic Index)
时间窗: From enrollment to the 3-month follow-up after the procedure.
It is an index ranging from 0 to 100 for classifying the severity of TMD. A score of 0-15 indicates no TMD, 20-40 indicates mild TMD, 25-65 indicates moderate TMD, and 70-100 indicates severe TMD.
USG examination
时间窗: From enrollment to the 3-month follow-up after the procedure.
Evaluation of Changes in Bruxism Symptoms with scales (Basic Scale on Insomnia Complaint and Quality of Sleep)
时间窗: From enrollment to the 3-month follow-up after the procedure.
It is a scoring system between 0 and 28. A score of 0 indicates no problems related to sleep, while a score of 28 represents severe insomnia complaints and poor sleep quality.
Satisfaction Survey
时间窗: From enrollment to the 3-month follow-up after the procedure.
It is a scoring system between 1 and 5. A score of 1 indicates complete dissatisfaction, while a score of 5 indicates a high level of satisfaction.
次要结局
未报告次要终点