The Effect of Botulinum Toxin Type A on Quality of Life During Bruxism Treatment: A Randomized Controlled Trial Comparing Botulinum Toxin Type A With Oral Ibuprofen in Patients With Jaw Muscle Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Forty participants diagnosed with sleep bruxism were randomly assigned to receive either Botulinum Toxin Type A injections into the masseter and temporalis muscles or oral ibuprofen therapy. Participants were followed for 20 weeks. The primary outcome was pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), muscle tenderness, and mandibular function.
详细描述
Bruxism is a parafunctional masticatory muscle activity characterized by repetitive clenching or grinding of the teeth and/or bracing or thrusting of the mandible. It is commonly associated with jaw muscle pain, muscle tenderness, fatigue, restricted mandibular movement, and impairment of oral health-related quality of life. Conventional treatment strategies include behavioral interventions, occlusal splints, physical therapy, and pharmacological agents such as non-steroidal anti-inflammatory drugs (NSAIDs). However, these approaches may not provide adequate symptom control in all patients, particularly those with persistent muscular pain.
Botulinum Toxin Type A has been increasingly investigated as an alternative therapeutic option because it produces temporary chemodenervation by inhibiting the presynaptic release of acetylcholine at the neuromuscular junction. This mechanism reduces excessive muscle contraction and may alleviate pain, decrease muscle tenderness, and improve mandibular function. Despite encouraging evidence from previous studies, further randomized controlled trials comparing Botulinum Toxin Type A with conventional pharmacological therapy remain necessary to establish its clinical effectiveness.
The present study was designed as a prospective, randomized, controlled clinical trial conducted at the Department of Dentistry, New Cyprus Health and Social Sciences University. Forty adult patients diagnosed with sleep bruxism associated with jaw muscle pain were enrolled after meeting the predefined eligibility criteria and providing written informed consent. Participants were randomly allocated into two equal treatment groups. The intervention group received Botulinum Toxin Type A injections administered into the bilateral masseter and temporalis muscles according to the study protocol, whereas the control group received oral ibuprofen therapy.
Clinical assessments were performed at baseline and during a 20-week follow-up period. Pain intensity was evaluated using the Visual Analogue Scale (VAS), while oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Additional clinical outcomes included muscle tenderness on palpation and mandibular function. Safety assessments were conducted throughout the study by monitoring treatment-related adverse events and documenting any unexpected clinical findings.
The primary objective of this trial was to compare the effectiveness of Botulinum Toxin Type A with oral ibuprofen in reducing pain intensity in patients with sleep bruxism. Secondary objectives included evaluating changes in oral health-related quality of life, muscle tenderness, mandibular function, and the overall clinical response following treatment. The findings of this study are intended to provide evidence regarding the comparative effectiveness of Botulinum Toxin Type A as a minimally invasive treatment option for patients experiencing jaw muscle pain related to sleep bruxism.
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
- None
盲法说明
Due to the nature of the interventions (Botulinum Toxin Type A injections versus oral ibuprofen therapy), blinding of participants and the treating investigator was not feasible. Outcome assessment was based on standardized patient-reported outcome measures (VAS and OHIP-14), and statistical analyses were performed using coded data to minimize analytical bias.
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
- 否
入选标准
- •Adults aged 18 years or older.
- •Clinical diagnosis of sleep bruxism.
- •Presence of jaw muscle pain.
- •Ability to provide written informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Previous botulinum toxin treatment within 6 months.
- •Neuromuscular disorders.
- •Allergy to botulinum toxin or ibuprofen.
- •Use of medications affecting neuromuscular function.
研究组 & 干预措施
Oral Ibuprofen
Participants in this arm received oral ibuprofen with 600 mg administered three times daily for one week.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Change in Pain Intensity Measured by the Visual Analogue Scale (VAS)
时间窗: Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).
Pain intensity will be assessed using the 10-point Visual Analogue Scale (VAS). Participants will mark their pain level on a horizontal line ranging from 0 (no pain) to 10 (worst pain imaginable). Pain severity may be interpreted as mild (1-3), moderate (4-6), or severe (7-9). The outcome measure will be the mean change in VAS score from baseline to each follow-up assessment. Lower scores indicate reduced pain intensity and improved treatment outcome.
次要结局
- Change in Oral Health-Related Quality of Life (OHIP-14)(Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).)
- Change in Jaw Muscle Tenderness Assessed by Standardized Clinical Palpation(Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).)
- Change in Mandibular Functional Performance Assessed by Clinical Examination(Baseline to Week 20 (week 1, week 2, week 4, week 8, week 12, week 16, and week 20).)
研究者
Faisal Omar Basheer Mojbur
Principal Investigator
NEW Cyprus Health and Social Sciences University