Influence of Vertical Facial Morphology on Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism: A Prospective T-Scan Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Center of Force (CoF)
研究概览
简要总结
This study investigated whether the shape of the face affects how jaw muscles respond to botulinum toxin injections in people who grind their teeth (bruxism). Participants were divided into two groups based on their facial structure: low-angle (shorter face height) and normal-angle. Each participant received botulinum toxin type A injections into the masseter (jaw) muscle. Bite force measurements were taken before and 15 days after the injection using the T-Scan computerized occlusal analysis system. The study aimed to determine whether facial structure influences the early changes in bite force balance following the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years
- •Confirmed bruxism diagnosis through self-report and clinical signs
- •Full permanent dentition excluding third molars
- •Angle Class I molar relationship
- •No previous BTX-A injection within 6 months
- •GoGn/SN angle between 18° and 38° on lateral cephalometric radiograph
排除标准
- •Systemic neuromuscular disorders
- •Known allergy to botulinum toxin or its excipients
- •Pregnancy or breastfeeding
- •Active infection at the injection site
- •Concurrent use of medications known to interact with BTX-A
- •History of orthognathic surgery or prior temporomandibular joint surgery
研究组 & 干预措施
Masseter BTX-A Injection (Low-Angle and Normal-Angle Subgroups)
Patients with bruxism received bilateral masseter muscle injections of 25 units of botulinum toxin type A (Botox®, Allergan) per side. T-Scan occlusal force measurements were performed at baseline (T0) and day 15 post-injection (T1). Participants were stratified into low-angle and normal-angle subgroups based on GoGn/SN cephalometric angle.
干预措施: Botulinum Toxin Type A (BOTOX) Injection (Biological)
结局指标
主要结局
Change in Center of Force (CoF)
时间窗: Baseline (T0) and day 15 post-injection (T1)
The Center of Force (CoF) represents the geometric center of the total occlusal force distribution, measured using the T-Scan Novus™ computerized occlusal analysis system (version 10.0.40; Tekscan, Inc., South Boston, MA, USA). CoF values closer to zero indicate greater bilateral occlusal balance. Within-group changes (T0 to T1) and between-group differences were assessed and compared between low-angle (GoGn/SN \< 26°) and normal-angle (GoGn/SN 26-38°) subgroups.
次要结局
- Change in Anterior and Posterior Force Percentage(Baseline (T0) and day 15 post-injection (T1))
研究者
Fatma Macit
Principal Investigator
Biruni University