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临床试验/NCT07028151
NCT07028151Enrolling By Invitation不适用

Comparison of the Effects of Classical Massage and Conventional Treatment Methods in Phone Addicted Bruxist Patients

Bartın Unıversity1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Pain Level

研究概览

简要总结

Bruxism, defined as the involuntary clenching or grinding of teeth during sleep or wakefulness, is a common condition with multifactorial etiology. It can lead to various complications including temporomandibular joint (TMJ) pain, masticatory muscle hypertrophy, dental wear, headaches, and postural dysfunction. Although its underlying causes remain unclear, stress, poor sleep quality, postural problems, and excessive smartphone use have been identified as potential contributing factors.

Recent studies suggest a significant relationship between bruxism and psychological as well as behavioral variables such as stress levels, screen time, and physical inactivity. University students, due to academic pressure and lifestyle habits, may be particularly vulnerable.

This study aims to investigate the relationship between bruxism and smartphone addiction, sleep quality, and perceived stress among associate degree students at Bartın University. By identifying these associations, the study seeks to contribute to preventive strategies and promote awareness of bruxism-related risk factors in young adults.

详细描述

Bruxism is a common multidisciplinary condition characterized by involuntary teeth clenching or grinding that occurs during sleep or wakefulness. Although bruxism episodes are typically short in duration, they can lead to significant complications involving the masticatory muscles and postural system, including temporomandibular joint (TMJ) pain and dysfunction, headaches, dental wear, hypersensitivity, tooth pain, hypertrophy of the masticatory muscles, implant fractures, and joint sounds. While its etiology is not fully understood, bruxism is believed to be multifactorial. Studies suggest that a lifestyle characterized by chronic stress and smartphone dependency may trigger or exacerbate bruxism. Additionally, poor sleep quality and postural abnormalities have been shown to influence both bruxism and emotional stress levels, while low levels of physical activity may further impair sleep and increase stress.

The aim of this study is to improve symptoms and enhance the quality of life in individuals with smartphone addiction and bruxism complaints through the application of different physiotherapy interventions.

Following the approval of the Ethics Committee of Bartın University Vocational School of Health Services, the study will be initiated. Data collection will take place between May 2025 and September 2025. A total of 30 university students diagnosed with bruxism and enrolled at Bartın University will be included in the study. Participants will be randomly assigned using a coin toss method into two groups: a massage group (MG, n=15) receiving classical face and neck massage, and a treatment group (TG, n=15) undergoing a conventional physiotherapy program including transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and infrared heat therapy.

After obtaining written informed consent from eligible participants, all assessments will be conducted in the same order by a blinded assessor. Following baseline evaluations, participants will undergo 10 sessions of their respective treatment protocols, each lasting approximately 40 minutes. The MG will receive classical massage, while the TG will receive TENS, ultrasound, and infrared therapy. After completion of the intervention sessions, post-treatment evaluations will be carried out by the same assessor, and the data will be subjected to statistical analysis.

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
Single (Outcomes Assessor)

盲法说明

To ensure blinding, baseline and final outcome measurements were performed by researchers other than the physiotherapist performing manual therapy and Conventional Treatment.

入排标准

年龄范围
18 Years 至 27 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Volunteer students aged between 18-27
  • •Having at least two clinical signs of bruxism Abnormal tooth wear on the occlusal surfaces of the teeth Abfraction Gingival recession and/or cervical defect Tongue indentations or damage to the inside of the cheek Tense facial and jaw muscles, muscle sensitivity, and masseteric hypertrophy upon bidigital palpation

排除标准

  • •Characterized by a neurological disease,
  • •Botulinum toxin injections into the masticatory muscles in the last year,
  • •Using antidepressant-type medications that will affect the central nervous system,
  • •Receiving occlusal splint treatment,

研究组 & 干预措施

Manual Therapy

Experimental

Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will receive 10 sessions of approximately 40 minutes of classical face and neck massage

干预措施: manual therapy (Other)

Conventional Therapy

Experimental

Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will commence the treatment sessions. Each session will consist of sequential applications of infrared therapy, ultrasound, and transcutaneous electrical nerve stimulation (TENS). The sessions, lasting approximately 40 minutes each, will be conducted over a total of 10 days

干预措施: Conventional Therapy (Other)

结局指标

主要结局

Pain Level

时间窗: From baseline to the end of treatment at 10 days

A visual analog scale (VAS) will be used to assess the severity of pain associated with bruxism. The patient will be asked to mark the severity of pain perceived at rest, during active use, and at night on a 10 cm long horizontal line with the words "0 (no pain)" at the beginning and "10 (most intense pain)" at the end. The individual's pain severity will be recorded by measuring the distance marked on the line in millimeters.

Pressure pain threshold

时间窗: From baseline to the end of treatment at 10 days

Pressure pain threshold measurement will be used for digital algometer (Lafayette Manual Muscle Test System ™, Model 01163, Lafayette Instrument Company, Lafayette, In, USA). Before the measurement, all individuals will be informed about the test. During the measurement, individuals will be asked to sit in a comfortable and neutral position in a comfortable and neutral position to come into contact with the soles of the foot. Masseter and temporalis anterior's most swollen, upper trapeze is painful nervous point. The pressure will be applied with a disk head of 1 cm² and the power unit will be set to kg/cm². Values will be recorded by telling the patient to give a "stop" command as soon as he first feels the pain. The averages will be taken twice from the same point.

次要结局

  • Range of motion(From baseline to the end of treatment at 10 days)
  • The Depression-Anxiety-Stress Scale (DAS)(From baseline to the end of treatment at 10 days)
  • Insomnia Severity Index (ISI)(From baseline to the end of treatment at 10 days)
  • Bruxism(From baseline to the end of treatment at 10 days)

研究者

发起方
Bartın Unıversity
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miraç Sezer

lecturer

Bartın Unıversity

研究点 (1)

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